A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Study Details
Study Description
Brief Summary
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Atezo-G-Benda (Safety Run-In and Expansion Phases) Safety run-in phase: Participants with previously untreated or relapsed or refractory FL will receive obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL will receive same treatment regimen as described for safety run-in phase. |
Drug: Atezolizumab
Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25.
Other Names:
Drug: Bendamustine
Bendamustine will be administered at a dose of 90 milligrams per square meter (mg/m^2) IV on Days 1 and 2 of Cycles 1-6, during induction treatment.
Drug: Obinutuzumab
Atezo-G-Benda: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6, during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6 during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1 during maintenance treatment.
Other Names:
|
| Experimental: Atezo-G-CHOP (Safety Run-In Phase) Safety run-in phase: Participants with previously untreated or relapsed or refractory FL will receive obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
Drug: Atezolizumab
Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25.
Other Names:
Drug: Cyclophosphamide
Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
Drug: Doxorubicin
Doxorubicin will be administered at a dose of 50 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
Drug: Obinutuzumab
Atezo-G-Benda: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6, during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6 during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1 during maintenance treatment.
Other Names:
Drug: Prednisone
Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6/8, during induction treatment. Prednisolone may be given if prednisone is unavailable. The 40 mg/m^2 dose of prednisone on Day 1 will be replaced by oral corticosteroids given as premedication on Day 1 of Cycle 1 (and subsequent cycles).
Drug: Vincristine
Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 1 of Cycle 1-6/8, during induction treatment.
|
| Experimental: Atezo-R-CHOP (Expansion Phase) Participants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
Drug: Atezolizumab
Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25.
Other Names:
Drug: Cyclophosphamide
Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
Drug: Doxorubicin
Doxorubicin will be administered at a dose of 50 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
Drug: Prednisone
Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6/8, during induction treatment. Prednisolone may be given if prednisone is unavailable. The 40 mg/m^2 dose of prednisone on Day 1 will be replaced by oral corticosteroids given as premedication on Day 1 of Cycle 1 (and subsequent cycles).
Drug: Vincristine
Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 1 of Cycle 1-6/8, during induction treatment.
Drug: Rituximab
Atezo-R-CHOP: Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria [Up to approximately 6 months]
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL participants with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With Adverse Events [Baseline up to approximately 4 years]
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Secondary Outcome Measures
- Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria [Up to approximately 6 months]
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria [Up to approximately 6 months]
Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria [Up to approximately 6 months]
Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy.
- Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria [Up to approximately 6 months]
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria [Up to approximately 6 months]
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria [Up to approximately 6 months]
Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria [Up to approximately 6 months]
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.
- Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria [Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])]
CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy.
- Observed Serum Obinutuzumab Concentration [Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)]
Predose time point was "any time prior to dose" for Cycle (Cy) 1 and "within 5 hour prior to dose" for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour.
- Observed Serum Atezolizumab Concentration [Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)]
Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was "within 5 hour prior to dose" for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes.
- Observed Serum Rituximab Concentration [Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)]
Predose time point was "any time prior to dose" for Cycle 1 and "within 5 hour prior to dose" for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour.
- Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab [Baseline up to approximately 4 years]
Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years)
- Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab [Baseline up to approximately 4 years]
Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years)
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [Baseline up to approximately 4 years]
Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was "any time prior to dose" for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
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For participants enrolled in the safety run-in phase: lymphoma classified as either relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a FL that requires treatment
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For participants enrolled in the expansion phase: lymphoma classified as either previously untreated Grade 1, 2, or 3a FL that requires treatment or previously untreated advanced DLBCL
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Histologically documented cluster of differentiation 20 (CD20) positive lymphoma
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Fluorodeoxyglucose-avid lymphoma
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At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
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Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
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For women who are not postmenopausal or surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than [<] 1 percent [%] per year during the treatment period and for at least 18 months after the last dose of study treatment for participants in the Atezo-G-benda and Atezo-G-CHOP treatment groups or for at least 12 months after the last dose of study treatment for participants in the Atezo-R-CHOP treatment group
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For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria:
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Histological evidence of transformation of FL into high-grade B-cell non-Hodgkin's lymphoma (NHL)
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Central nervous system lymphoma or leptomeningeal infiltration
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For participants with DLBCL: preplanned consolidative radiotherapy
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Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
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For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
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History of solid organ transplantation
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History of severe allergic or anaphylactic reaction or known sensitivity to humanized or murine monoclonal antibodies
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Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab, obinutuzumab, rituximab, or bendamustine formulation, including mannitol
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Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
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History of progressive multifocal leukoencephalopathy
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Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1
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History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
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Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, or anticipation of a major surgical procedure during the course of the study
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For participants who will be receiving CHOP: left ventricular ejection fraction (LVEF) <50% by multiple-gated acquisition (MUGA) scan or echocardiogram
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Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | United States | 80012 |
| 2 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 3 | University Miami | Miami | Florida | United States | 33136 |
| 4 | New York Uni Medical Center | New York | New York | United States | 10016 |
| 5 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 6 | Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute | Springfield | Oregon | United States | 97477 |
| 7 | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 8 | Texas Oncology | Austin | Texas | United States | 78705 |
| 9 | Texas Oncology-Tyler | Irving | Texas | United States | 75063 |
| 10 | Concord Repatriation General Hospital; Haematology | Sydney | New South Wales | Australia | 2139 |
| 11 | Calvary Mater Newcastle | Waratah | New South Wales | Australia | 2298 |
| 12 | The Queen Elizabeth Hospital; Haematology/Oncology | Woodville South | South Australia | Australia | 5011 |
| 13 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 14 | Austin Hospital | Heidelberg | Victoria | Australia | 3084 |
| 15 | Azienda Ospedaliera S. Orsola-Malpighi | Bologna | Emilia-Romagna | Italy | 40138 |
| 16 | Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Meldola | Emilia-Romagna | Italy | 47014 |
| 17 | Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia | Ravenna | Emilia-Romagna | Italy | 48100 |
| 18 | Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | Italy | 47900 |
| 19 | AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette | Torino | Lazio | Italy | 10126 |
| 20 | Asst Papa Giovanni XXIII | Bergamo | Lombardia | Italy | 24100 |
| 21 | Azienda Ospedaliera Univ | Firenze | Toscana | Italy | 50141 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.- BO29563
- 2015-001364-19
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 15 sites in 3 countries (Italy, Australia, and USA). |
|---|---|
| Pre-assignment Detail | Out of the 117 subjects who were screened for this study, 91 subjects were enrolled to either FL treatment cohort (Atezo-G-Benda, Atezo-G-CHOP) or DLBCL cohort (Atezo-R-CHOP) and 26 subjects failed screening. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Period Title: Overall Study | |||
| STARTED | 42 | 7 | 42 |
| COMPLETED | 32 | 5 | 33 |
| NOT COMPLETED | 10 | 2 | 9 |
Baseline Characteristics
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) | Total |
|---|---|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. | Total of all reporting groups |
| Overall Participants | 42 | 7 | 42 | 91 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
35
83.3%
|
6
85.7%
|
20
47.6%
|
61
67%
|
| >=65 years |
7
16.7%
|
1
14.3%
|
22
52.4%
|
30
33%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
55.6
(10.9)
|
57.4
(5.4)
|
59.2
(15.7)
|
57.4
(13.1)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
20
47.6%
|
4
57.1%
|
16
38.1%
|
40
44%
|
| Male |
22
52.4%
|
3
42.9%
|
26
61.9%
|
51
56%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
3
7.1%
|
0
0%
|
2
4.8%
|
5
5.5%
|
| Not Hispanic or Latino |
36
85.7%
|
7
100%
|
37
88.1%
|
80
87.9%
|
| Unknown or Not Reported |
3
7.1%
|
0
0%
|
3
7.1%
|
6
6.6%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
7.1%
|
1
14.3%
|
0
0%
|
4
4.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
37
88.1%
|
6
85.7%
|
40
95.2%
|
83
91.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
4.8%
|
0
0%
|
2
4.8%
|
4
4.4%
|
Outcome Measures
| Title | Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria |
|---|---|
| Description | Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL participants with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of relapsed/refractory [r/r] FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
75
178.6%
|
77.5
1107.1%
|
| Title | Percentage of Participants With Adverse Events |
|---|---|
| Description | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Time Frame | Baseline up to approximately 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 42 | 7 | 42 |
| Number [percentage of participants] |
100
238.1%
|
100
1428.6%
|
100
238.1%
|
| Title | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
|---|---|
| Description | Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
87.5
208.3%
|
77.5
1107.1%
|
| Title | Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
|---|---|
| Description | Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
75.0
178.6%
|
77.5
1107.1%
|
| Title | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
|---|---|
| Description | Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
80.0
190.5%
|
75.0
1071.4%
|
| Title | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
|---|---|
| Description | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
90.0
214.3%
|
90.0
1285.7%
|
| Title | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
|---|---|
| Description | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
95.0
226.2%
|
87.5
1250%
|
| Title | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria |
|---|---|
| Description | Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
90.0
214.3%
|
87.5
1250%
|
| Title | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
|---|---|
| Description | Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Time Frame | Up to approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
95.0
226.2%
|
87.5
1250%
|
| Title | Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria |
|---|---|
| Description | CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. |
| Time Frame | Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All PET evaluable 1L FL and 1L DLBCL patients that received at least one dose of atezolizumab. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 40 | 40 |
| Number (90% Confidence Interval) [percentage of participants] |
80.0
190.5%
|
75.0
1071.4%
|
| Title | Observed Serum Obinutuzumab Concentration |
|---|---|
| Description | Predose time point was "any time prior to dose" for Cycle (Cy) 1 and "within 5 hour prior to dose" for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. |
| Time Frame | Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) |
|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| Measure Participants | 42 | 7 |
| C1 Cmax after 1st infusion |
329
|
400
|
| C1 Cmin after the last infusion on C1 |
322
|
399
|
| C6 - Cmax after last dosing of induction |
544
|
659
|
| C6 - Cmin after last dosing of induction |
203
|
245
|
| Title | Observed Serum Atezolizumab Concentration |
|---|---|
| Description | Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was "within 5 hour prior to dose" for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes. |
| Time Frame | Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample. 0 represents no data was collected at that cycle. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-R-CHOP Cohort (Expansion Phase) | Atezo-G-CHOP Cohort (Safety Run-In Phase) |
|---|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| Measure Participants | 42 | 42 | 7 |
| Cycle 2 - Cmax after 1st infusion |
275
|
332
|
424
|
| C2 - Cmin before 2nd infusion |
83
|
82.1
|
94
|
| C6 - Cmin after 6th infusion |
256
|
195
|
|
| C8 - Cmax after 7th infusion |
486.5
|
||
| C8 - Cmin before 8th infusion |
184
|
| Title | Observed Serum Rituximab Concentration |
|---|---|
| Description | Predose time point was "any time prior to dose" for Cycle 1 and "within 5 hour prior to dose" for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. |
| Time Frame | Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of study treatment and who provided at least one PK sample. |
| Arm/Group Title | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|
| Arm/Group Description | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 42 |
| C1 - Cmax after dosing C1 |
159
|
| C1 - Ctrough after dosing C1 |
26.1
|
| C8 - Cmax after dosing C8 |
229
|
| C8 - Ctrough after dosing C8 |
105.5
|
| Title | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
|---|---|
| Description | Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) |
| Time Frame | Baseline up to approximately 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-G-Benda cohort |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) |
|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. |
| Measure Participants | 42 |
| Induction Cycle 1 Day 1 |
2.4
5.7%
|
| Induction Cycle 5 Day 1 |
0
0%
|
| Induction Cycle 6 Day 1 |
0
0%
|
| Maintenance Month 1 |
0
0%
|
| Study Drug Completion or Early Discontinuation |
0
0%
|
| Obinutuzumab Day 120 Follow up |
0
0%
|
| Title | Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
|---|---|
| Description | Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) |
| Time Frame | Baseline up to approximately 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-R-CHOP cohort. |
| Arm/Group Title | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|
| Arm/Group Description | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 42 |
| Baseline |
14.3
34%
|
| Induction Cycle 1 Day 1 |
0
0%
|
| Induction Cycle 5 Day 1 |
0
0%
|
| Induction Cycle 8 Day 1 |
0
0%
|
| Rituximab Day 120 Follow up |
0
0%
|
| Rituximab 1 Year Follow up |
0
0%
|
| Study Drug Completion or Early Discontinuation |
0
0%
|
| Title | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
|---|---|
| Description | Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was "any time prior to dose" for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported. |
| Time Frame | Baseline up to approximately 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consisted of all participants who received at least one dose of study drug. |
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) |
|---|---|---|---|
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| Measure Participants | 42 | 7 | 42 |
| Baseline |
2.4
5.7%
|
0
0%
|
14.3
34%
|
| Induction Cycle 2 Day 1 |
0
0%
|
0
0%
|
2.6
6.2%
|
| Consolidation Cycle 16 |
5.9
14%
|
||
| Atezolizumab Day 120 Follow up |
0
0%
|
0
0%
|
9.1
21.7%
|
| Atezo PK and Immunogenicity Follow Up (1YR) |
0
0%
|
0
0%
|
5.6
13.3%
|
Adverse Events
| Time Frame | Baseline up to approximately 4 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety population is defined as all patients who received at least one dose of the study medication. | |||||
| Arm/Group Title | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) | |||
| Arm/Group Description | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. | |||
All Cause Mortality |
||||||
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/42 (11.9%) | 1/7 (14.3%) | 5/42 (11.9%) | |||
Serious Adverse Events |
||||||
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/42 (45.2%) | 2/7 (28.6%) | 18/42 (42.9%) | |||
| Blood and lymphatic system disorders | ||||||
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| FEBRILE NEUTROPENIA | 4/42 (9.5%) | 4 | 1/7 (14.3%) | 1 | 6/42 (14.3%) | 7 |
| NEUTROPENIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| THROMBOCYTOPENIA | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Cardiac disorders | ||||||
| ATRIAL FIBRILLATION | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| ATRIAL TACHYCARDIA | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| CARDIAC ARREST | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| MYOCARDITIS | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| HYPOACUSIS | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Eye disorders | ||||||
| DIPLOPIA | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL PAIN | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| IMMUNE-MEDIATED ENTEROCOLITIS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| INTESTINAL OBSTRUCTION | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| NAUSEA | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| PANCREATITIS | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| SMALL INTESTINAL OBSTRUCTION | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| General disorders | ||||||
| PYREXIA | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| SUDDEN DEATH | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| CHOLECYSTITIS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Infections and infestations | ||||||
| DIVERTICULITIS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| EPSTEIN-BARR VIRUS INFECTION | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| GASTROENTERITIS SALMONELLA | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| KIDNEY INFECTION | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PNEUMONIA | 5/42 (11.9%) | 5 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| PNEUMONIA INFLUENZAL | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| PNEUMONIA VIRAL | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| SEPSIS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| SINUSITIS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| SKIN INFECTION | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| UPPER RESPIRATORY TRACT INFECTION | 2/42 (4.8%) | 2 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| URINARY TRACT INFECTION | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| INFUSION RELATED REACTION | 2/42 (4.8%) | 2 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| ADENOCARCINOMA | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| ADENOCARCINOMA OF COLON | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| COLON CANCER | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Nervous system disorders | ||||||
| MIGRAINE | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| SYNCOPE | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Renal and urinary disorders | ||||||
| ACUTE KIDNEY INJURY | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| DYSPNOEA | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| LARYNGEAL INFLAMMATION | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| OBLITERATIVE BRONCHIOLITIS | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| PULMONARY EMBOLISM | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Atezo-R-CHOP Cohort (Expansion Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/42 (100%) | 7/7 (100%) | 42/42 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 6/42 (14.3%) | 8 |
| IRON DEFICIENCY ANAEMIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| LYMPH NODE PAIN | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| NEUTROPENIA | 14/42 (33.3%) | 22 | 3/7 (42.9%) | 6 | 22/42 (52.4%) | 31 |
| THROMBOCYTOPENIA | 4/42 (9.5%) | 6 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Cardiac disorders | ||||||
| BRADYCARDIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PALPITATIONS | 2/42 (4.8%) | 2 | 2/7 (28.6%) | 2 | 1/42 (2.4%) | 1 |
| Endocrine disorders | ||||||
| HYPOPHYSITIS | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| HYPOTHYROIDISM | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| Eye disorders | ||||||
| DRY EYE | 2/42 (4.8%) | 2 | 2/7 (28.6%) | 2 | 3/42 (7.1%) | 3 |
| OCULAR HYPERAEMIA | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PHOTOPHOBIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| VISION BLURRED | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL DISCOMFORT | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| ABDOMINAL PAIN | 8/42 (19%) | 10 | 2/7 (28.6%) | 3 | 5/42 (11.9%) | 5 |
| ABDOMINAL PAIN UPPER | 6/42 (14.3%) | 7 | 0/7 (0%) | 0 | 4/42 (9.5%) | 4 |
| ASCITES | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| COLITIS | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| CONSTIPATION | 18/42 (42.9%) | 27 | 3/7 (42.9%) | 4 | 18/42 (42.9%) | 26 |
| DEFAECATION URGENCY | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| DIARRHOEA | 20/42 (47.6%) | 47 | 3/7 (42.9%) | 10 | 14/42 (33.3%) | 23 |
| DRY MOUTH | 5/42 (11.9%) | 5 | 0/7 (0%) | 0 | 4/42 (9.5%) | 4 |
| DUODENAL ULCER HAEMORRHAGE | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| DYSPEPSIA | 8/42 (19%) | 11 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 3 |
| FLATULENCE | 3/42 (7.1%) | 4 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 3/42 (7.1%) | 3 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| GLOSSITIS | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| HAEMATOCHEZIA | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| HAEMORRHOIDAL HAEMORRHAGE | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| NAUSEA | 22/42 (52.4%) | 42 | 5/7 (71.4%) | 8 | 13/42 (31%) | 22 |
| RECTAL DISCHARGE | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| STEATORRHOEA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| STOMATITIS | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 3/42 (7.1%) | 5 |
| VOMITING | 11/42 (26.2%) | 15 | 2/7 (28.6%) | 3 | 9/42 (21.4%) | 11 |
| General disorders | ||||||
| ASTHENIA | 3/42 (7.1%) | 5 | 0/7 (0%) | 0 | 2/42 (4.8%) | 4 |
| CHEST DISCOMFORT | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| CHEST PAIN | 10/42 (23.8%) | 10 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 4 |
| CHILLS | 3/42 (7.1%) | 5 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| FATIGUE | 23/42 (54.8%) | 27 | 5/7 (71.4%) | 6 | 17/42 (40.5%) | 22 |
| FEELING COLD | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| INFLUENZA LIKE ILLNESS | 7/42 (16.7%) | 9 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| MUCOSAL INFLAMMATION | 1/42 (2.4%) | 2 | 2/7 (28.6%) | 3 | 3/42 (7.1%) | 5 |
| OEDEMA PERIPHERAL | 3/42 (7.1%) | 3 | 1/7 (14.3%) | 1 | 3/42 (7.1%) | 4 |
| PAIN | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PERIPHERAL SWELLING | 3/42 (7.1%) | 3 | 1/7 (14.3%) | 2 | 1/42 (2.4%) | 1 |
| PYREXIA | 10/42 (23.8%) | 12 | 0/7 (0%) | 0 | 5/42 (11.9%) | 9 |
| Hepatobiliary disorders | ||||||
| CHOLELITHIASIS | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Immune system disorders | ||||||
| SEASONAL ALLERGY | 3/42 (7.1%) | 5 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| Infections and infestations | ||||||
| BRONCHITIS | 4/42 (9.5%) | 4 | 1/7 (14.3%) | 2 | 0/42 (0%) | 0 |
| CONJUNCTIVITIS | 2/42 (4.8%) | 2 | 2/7 (28.6%) | 2 | 0/42 (0%) | 0 |
| HERPES ZOSTER | 2/42 (4.8%) | 2 | 2/7 (28.6%) | 2 | 1/42 (2.4%) | 1 |
| NASOPHARYNGITIS | 5/42 (11.9%) | 8 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| ORAL CANDIDIASIS | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 2 | 0/42 (0%) | 0 |
| ORAL HERPES | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| PHARYNGITIS STREPTOCOCCAL | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PNEUMONIA | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| SINUSITIS | 7/42 (16.7%) | 7 | 1/7 (14.3%) | 1 | 5/42 (11.9%) | 5 |
| SKIN INFECTION | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| UPPER RESPIRATORY TRACT INFECTION | 12/42 (28.6%) | 22 | 1/7 (14.3%) | 1 | 7/42 (16.7%) | 7 |
| URINARY TRACT INFECTION | 6/42 (14.3%) | 8 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 2 |
| VULVOVAGINAL MYCOTIC INFECTION | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| FALL | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 3/42 (7.1%) | 5 |
| INFUSION RELATED REACTION | 29/42 (69%) | 45 | 2/7 (28.6%) | 2 | 16/42 (38.1%) | 16 |
| JOINT DISLOCATION | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| LIGAMENT SPRAIN | 0/42 (0%) | 0 | 1/7 (14.3%) | 2 | 0/42 (0%) | 0 |
| MENISCUS INJURY | 0/42 (0%) | 0 | 2/7 (28.6%) | 2 | 0/42 (0%) | 0 |
| POST PROCEDURAL HAEMATURIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PROCEDURAL PAIN | 2/42 (4.8%) | 3 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| SKIN LACERATION | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Investigations | ||||||
| AMYLASE INCREASED | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| LIPASE INCREASED | 13/42 (31%) | 14 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 6 |
| WEIGHT DECREASED | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 6/42 (14.3%) | 6 | 2/7 (28.6%) | 2 | 1/42 (2.4%) | 1 |
| DEHYDRATION | 2/42 (4.8%) | 3 | 2/7 (28.6%) | 2 | 2/42 (4.8%) | 2 |
| HYPERGLYCAEMIA | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| HYPOCALCAEMIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| HYPOKALAEMIA | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 8/42 (19%) | 10 | 2/7 (28.6%) | 4 | 9/42 (21.4%) | 12 |
| BACK PAIN | 10/42 (23.8%) | 10 | 4/7 (57.1%) | 6 | 8/42 (19%) | 13 |
| BONE PAIN | 4/42 (9.5%) | 6 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 5 |
| FLANK PAIN | 3/42 (7.1%) | 6 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| JOINT EFFUSION | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| JOINT SWELLING | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| MUSCLE SPASMS | 5/42 (11.9%) | 7 | 2/7 (28.6%) | 2 | 0/42 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 2/42 (4.8%) | 5 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 4 |
| MUSCULOSKELETAL PAIN | 4/42 (9.5%) | 4 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| MUSCULOSKELETAL STIFFNESS | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| MYALGIA | 2/42 (4.8%) | 3 | 1/7 (14.3%) | 1 | 5/42 (11.9%) | 5 |
| NECK PAIN | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| PAIN IN EXTREMITY | 8/42 (19%) | 10 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| ACROCHORDON | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| NEOPLASM | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| OVARIAN EPITHELIAL CANCER | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Nervous system disorders | ||||||
| AMNESIA | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 2 |
| BALANCE DISORDER | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| DIZZINESS | 7/42 (16.7%) | 12 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 6 |
| DYSGEUSIA | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 6/42 (14.3%) | 6 |
| HEADACHE | 19/42 (45.2%) | 25 | 1/7 (14.3%) | 1 | 8/42 (19%) | 13 |
| HYPOAESTHESIA | 4/42 (9.5%) | 4 | 2/7 (28.6%) | 3 | 1/42 (2.4%) | 1 |
| PARAESTHESIA | 3/42 (7.1%) | 5 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| PERIPHERAL SENSORY NEUROPATHY | 3/42 (7.1%) | 3 | 2/7 (28.6%) | 3 | 13/42 (31%) | 15 |
| TASTE DISORDER | 2/42 (4.8%) | 2 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| Product Issues | ||||||
| DEVICE OCCLUSION | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Psychiatric disorders | ||||||
| ANXIETY | 7/42 (16.7%) | 7 | 0/7 (0%) | 0 | 3/42 (7.1%) | 6 |
| INSOMNIA | 7/42 (16.7%) | 7 | 2/7 (28.6%) | 2 | 7/42 (16.7%) | 8 |
| MANIA | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Renal and urinary disorders | ||||||
| DYSURIA | 1/42 (2.4%) | 3 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| MICTURITION URGENCY | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| VAGINAL DISCHARGE | 2/42 (4.8%) | 2 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| VAGINAL HAEMORRHAGE | 0/42 (0%) | 0 | 1/7 (14.3%) | 2 | 0/42 (0%) | 0 |
| VULVOVAGINAL PAIN | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 25/42 (59.5%) | 31 | 5/7 (71.4%) | 9 | 12/42 (28.6%) | 18 |
| DYSPHONIA | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| DYSPNOEA | 7/42 (16.7%) | 8 | 1/7 (14.3%) | 1 | 3/42 (7.1%) | 4 |
| EPISTAXIS | 3/42 (7.1%) | 3 | 0/7 (0%) | 0 | 2/42 (4.8%) | 2 |
| HICCUPS | 0/42 (0%) | 0 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| NASAL CONGESTION | 8/42 (19%) | 8 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| OROPHARYNGEAL PAIN | 8/42 (19%) | 11 | 1/7 (14.3%) | 1 | 4/42 (9.5%) | 4 |
| PHARYNGEAL DISORDER | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| PRODUCTIVE COUGH | 4/42 (9.5%) | 4 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| RHINITIS ALLERGIC | 3/42 (7.1%) | 3 | 1/7 (14.3%) | 1 | 3/42 (7.1%) | 3 |
| RHINORRHOEA | 3/42 (7.1%) | 3 | 2/7 (28.6%) | 2 | 5/42 (11.9%) | 6 |
| SINUS CONGESTION | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| UPPER-AIRWAY COUGH SYNDROME | 1/42 (2.4%) | 1 | 0/7 (0%) | 0 | 3/42 (7.1%) | 4 |
| Skin and subcutaneous tissue disorders | ||||||
| ALOPECIA | 3/42 (7.1%) | 4 | 2/7 (28.6%) | 2 | 10/42 (23.8%) | 10 |
| DERMATITIS ACNEIFORM | 1/42 (2.4%) | 1 | 1/7 (14.3%) | 1 | 2/42 (4.8%) | 2 |
| DERMATITIS CONTACT | 0/42 (0%) | 0 | 1/7 (14.3%) | 2 | 0/42 (0%) | 0 |
| DRY SKIN | 4/42 (9.5%) | 4 | 1/7 (14.3%) | 1 | 1/42 (2.4%) | 1 |
| ERYTHEMA | 4/42 (9.5%) | 5 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| NIGHT SWEATS | 4/42 (9.5%) | 4 | 0/7 (0%) | 0 | 3/42 (7.1%) | 3 |
| PRURITUS | 12/42 (28.6%) | 14 | 0/7 (0%) | 0 | 4/42 (9.5%) | 4 |
| RASH | 14/42 (33.3%) | 22 | 0/7 (0%) | 0 | 4/42 (9.5%) | 6 |
| RASH MACULO-PAPULAR | 4/42 (9.5%) | 5 | 0/7 (0%) | 0 | 0/42 (0%) | 0 |
| RASH VESICULAR | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
| Vascular disorders | ||||||
| HYPERTENSION | 6/42 (14.3%) | 9 | 0/7 (0%) | 0 | 1/42 (2.4%) | 1 |
| PERIPHERAL COLDNESS | 0/42 (0%) | 0 | 1/7 (14.3%) | 1 | 0/42 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
- BO29563
- 2015-001364-19