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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)

A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Lymphoma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02596971
Enrollment
91
Registered
2015-11-04
Start date
2015-12-22
Completion date
2020-05-08
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma, Lymphoma Follicular

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.

Interventions

DRUGDoxorubicin

Doxorubicin will be administered at a dose of 50 mg/m\^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.

DRUGAtezolizumab

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.

DRUGBendamustine

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.

DRUGCyclophosphamide

Cyclophosphamide will be administered at a dose of 750 mg/m\^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.

DRUGObinutuzumab

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.

DRUGPrednisone

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).

DRUGVincristine

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.

DRUGRituximab

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.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * 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 * 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 * Histologically documented cluster of differentiation 20 (CD20) positive lymphoma * Fluorodeoxyglucose-avid lymphoma * At least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging) * Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL * 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 * For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

Exclusion criteria

* Histological evidence of transformation of FL into high-grade B-cell non-Hodgkin's lymphoma (NHL) * Central nervous system lymphoma or leptomeningeal infiltration * For participants with DLBCL: preplanned consolidative radiotherapy * 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 * 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 * History of solid organ transplantation * History of severe allergic or anaphylactic reaction or known sensitivity to humanized or murine monoclonal antibodies * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab, obinutuzumab, rituximab, or bendamustine formulation, including mannitol * Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening * History of progressive multifocal leukoencephalopathy * Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1 * History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results * 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 * For participants who will be receiving CHOP: left ventricular ejection fraction (LVEF) \<50% by multiple-gated acquisition (MUGA) scan or echocardiogram * Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 CriteriaUp to approximately 6 monthsPrimary 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 EventsBaseline up to approximately 4 yearsAn 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

MeasureTime frameDescription
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 CriteriaUp to approximately 6 monthsComplete 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 CriteriaUp to approximately 6 monthsObjective 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 CriteriaUp to approximately 6 monthsObjective 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 CriteriaUp to approximately 6 monthsTumor 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 CriteriaUp to approximately 6 monthsTumor 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 CriteriaBaseline 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.
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 CriteriaUp to approximately 6 monthsTumor 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.
Observed Serum Atezolizumab ConcentrationAtezo-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 ConcentrationPredose, 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 ObinutuzumabBaseline up to approximately 4 yearsInduction: 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 RituximabBaseline up to approximately 4 yearsInduction: 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 AtezolizumabBaseline up to approximately 4 yearsAtezo-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.
Observed Serum Obinutuzumab ConcentrationInduction: 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.
Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 CriteriaUp to approximately 6 monthsComplete 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.

Countries

Australia, Italy, United States

Participant flow

Recruitment details

The study was conducted at 15 sites in 3 countries (Italy, Australia, and USA).

Pre-assignment details

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.

Participants by arm

ArmCount
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)
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.
42
Atezo-G-CHOP Cohort (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.
7
Atezo-R-CHOP Cohort (Expansion 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.
42
Total91

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath515
Overall StudyWithdrawal by Subject514

Baseline characteristics

CharacteristicAtezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Atezo-G-CHOP Cohort (Safety Run-In Phase)Atezo-R-CHOP Cohort (Expansion Phase)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants1 Participants22 Participants30 Participants
Age, Categorical
Between 18 and 65 years
35 Participants6 Participants20 Participants61 Participants
Age, Continuous55.6 years
STANDARD_DEVIATION 10.9
57.4 years
STANDARD_DEVIATION 5.4
59.2 years
STANDARD_DEVIATION 15.7
57.4 years
STANDARD_DEVIATION 13.1
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants0 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants7 Participants37 Participants80 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants0 Participants3 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants4 Participants
Race (NIH/OMB)
White
37 Participants6 Participants40 Participants83 Participants
Sex: Female, Male
Female
20 Participants4 Participants16 Participants40 Participants
Sex: Female, Male
Male
22 Participants3 Participants26 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
5 / 421 / 75 / 42
other
Total, other adverse events
42 / 427 / 742 / 42
serious
Total, serious adverse events
19 / 422 / 718 / 42

Outcome results

Primary

Percentage of Participants With Adverse Events

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

Population: 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.

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Adverse Events100 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Adverse Events100 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Adverse Events100 percentage of participants
Primary

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

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria75 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria77.5 percentage of participants
Secondary

Observed Serum Atezolizumab Concentration

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)

Population: 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.

ArmMeasureGroupValue (MEDIAN)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Atezolizumab ConcentrationC6 - Cmin after 6th infusion256 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Atezolizumab ConcentrationCycle 2 - Cmax after 1st infusion275 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Atezolizumab ConcentrationC2 - Cmin before 2nd infusion83 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationC2 - Cmin before 2nd infusion82.1 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationC8 - Cmin before 8th infusion184 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationCycle 2 - Cmax after 1st infusion332 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationC8 - Cmax after 7th infusion486.5 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationC2 - Cmin before 2nd infusion94 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationC6 - Cmin after 6th infusion195 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Atezolizumab ConcentrationCycle 2 - Cmax after 1st infusion424 ug/mL
Secondary

Observed Serum Obinutuzumab Concentration

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)

Population: All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample.

ArmMeasureGroupValue (MEDIAN)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Obinutuzumab ConcentrationC1 Cmax after 1st infusion329 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Obinutuzumab ConcentrationC1 Cmin after the last infusion on C1322 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Obinutuzumab ConcentrationC6 - Cmax after last dosing of induction544 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Obinutuzumab ConcentrationC6 - Cmin after last dosing of induction203 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Obinutuzumab ConcentrationC6 - Cmin after last dosing of induction245 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Obinutuzumab ConcentrationC1 Cmax after 1st infusion400 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Obinutuzumab ConcentrationC6 - Cmax after last dosing of induction659 ug/mL
Atezo-R-CHOP Cohort (Expansion Phase)Observed Serum Obinutuzumab ConcentrationC1 Cmin after the last infusion on C1399 ug/mL
Secondary

Observed Serum Rituximab Concentration

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)

Population: All participants who received at least 1 dose of study treatment and who provided at least one PK sample.

ArmMeasureGroupValue (MEDIAN)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Rituximab ConcentrationC1 - Cmax after dosing C1159 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Rituximab ConcentrationC1 - Ctrough after dosing C126.1 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Rituximab ConcentrationC8 - Cmax after dosing C8229 ug/mL
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Observed Serum Rituximab ConcentrationC8 - Ctrough after dosing C8105.5 ug/mL
Secondary

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

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

Population: The analysis population consisted of all participants who received at least one dose of study drug.

ArmMeasureGroupValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezolizumab Day 120 Follow up0 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabInduction Cycle 2 Day 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabBaseline2.4 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezo PK and Immunogenicity Follow Up (1YR)0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabBaseline0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabInduction Cycle 2 Day 10 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezo PK and Immunogenicity Follow Up (1YR)0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezolizumab Day 120 Follow up0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabConsolidation Cycle 165.9 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabInduction Cycle 2 Day 12.6 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabBaseline14.3 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezolizumab Day 120 Follow up9.1 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabAtezo PK and Immunogenicity Follow Up (1YR)5.6 percentage of participants
Secondary

Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria

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])

Population: All PET evaluable 1L FL and 1L DLBCL patients that received at least one dose of atezolizumab.

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria80.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria75.0 percentage of participants
Secondary

Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria87.5 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria77.5 percentage of participants
Secondary

Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria80.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria75.0 percentage of participants
Secondary

Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria75.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria77.5 percentage of participants
Secondary

Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab

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

Population: The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-R-CHOP cohort.

ArmMeasureGroupValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabBaseline14.3 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabInduction Cycle 1 Day 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabInduction Cycle 5 Day 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabInduction Cycle 8 Day 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabRituximab 1 Year Follow up0 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabRituximab Day 120 Follow up0 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to RituximabStudy Drug Completion or Early Discontinuation0 percentage of participants
Secondary

Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab

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

Population: The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-G-Benda cohort

ArmMeasureGroupValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabInduction Cycle 6 Day 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabMaintenance Month 10 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabStudy Drug Completion or Early Discontinuation0 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabObinutuzumab Day 120 Follow up0 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabInduction Cycle 1 Day 12.4 percentage of participants
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to ObinutuzumabInduction Cycle 5 Day 10 percentage of participants
Secondary

Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria95.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria87.5 percentage of participants
Secondary

Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria95.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria87.5 percentage of participants
Secondary

Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria90.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria87.5 percentage of participants
Secondary

Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria

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

Population: 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).

ArmMeasureValue (NUMBER)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria90.0 percentage of participants
Atezo-R-CHOP Cohort (Expansion Phase)Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria90.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026