Trial Outcomes & Findings for A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT02729896)

Last Updated: 2020-12-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)

Results posted on

2020-12-23

Participant Flow

The study was conducted at 11 investigational centres in Germany (3), Poland (5) and USA (3).

Participant milestones

Participant milestones
Measure	Dose-Escalation FL Cohort 1.4 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-in and Expansion DLBCL Cohort For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Overall Study STARTED	3	10	23
Overall Study COMPLETED	1	1	1
Overall Study NOT COMPLETED	2	9	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose-Escalation FL Cohort 1.4 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-in and Expansion DLBCL Cohort For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Overall Study Death	0	2	13
Overall Study Lost to Follow-up	0	2	3
Overall Study Other	0	2	0
Overall Study Physician Decision	1	2	3
Overall Study Progressive Disease	0	1	0
Overall Study Withdrawal by Subject	1	0	3

Baseline Characteristics

A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-in and Expansion DLBCL Cohort n=23 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Total n=36 Participants Total of all reporting groups
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants	30 participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	20 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	52.3 Years STANDARD_DEVIATION 13.6 • n=5 Participants	57.7 Years STANDARD_DEVIATION 11.7 • n=7 Participants	64.3 Years STANDARD_DEVIATION 15.3 • n=5 Participants	61.5 Years STANDARD_DEVIATION 14.5 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants
Race/Ethnicity, Customized White	3 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants	33 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)

Population: Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=7 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=16 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan	33.33 Percentage of participants	14.30 Percentage of participants	12.50 Percentage of participants

SECONDARY outcome

Timeframe: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)

Population: Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.

Tumor response assessment was performed by investigator according to modified Lugano classification using computed tomography (CT) scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to \<= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=7 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=16 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone	0.00 Percentage of participants	57.14 Percentage of participants	12.50 Percentage of participants

SECONDARY outcome

Timeframe: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)

Population: Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available

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 PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=7 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=16 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans	33.33 Percentage of participants	57.14 Percentage of participants	25.00 Percentage of participants

SECONDARY outcome

Timeframe: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)

Population: Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available

Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to \<= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with \>= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes \& extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by \> 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=7 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=16 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone	33.33 Percentage of participants	57.14 Percentage of participants	25.00 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 35 months

Population: Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=7 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=16 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone Complete response	33.3 Percentage of participants	14.3 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone Partial response	0 Percentage of participants	42.9 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone Stable disease	33.3 Percentage of participants	14.3 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone Progressive disease	33.3 Percentage of participants	14.3 Percentage of participants	31.3 Percentage of participants
Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone Not available	0 Percentage of participants	14.3 Percentage of participants	37.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable 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. Grading was completed according to the CTCAE, version 4.0 for severity and tumor flare reactions were graded according to NCI CTCAE v3.0.

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=21 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Adverse Events and Serious Adverse Events	100.00 Percentage of participants	100.00 Percentage of participants	81.00 Percentage of participants

SECONDARY outcome

Timeframe: Pre-dose (0 hr) up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 4, 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and decreases every 30 min to maximum of 400 mg/hr)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Serum Obinutuzumab Concentration Maintenance Month 13 Pre-dose	78.8 mcg/mL Standard Deviation 42.8	158 mcg/mL Standard Deviation 1.41	—
Serum Obinutuzumab Concentration Induction cycle 1 Day 1 Pre-dose	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.	—
Serum Obinutuzumab Concentration Induction cycle 1 Day 1 Post-dose	308 mcg/mL Standard Deviation 41.6	295 mcg/mL Standard Deviation 171	—
Serum Obinutuzumab Concentration Induction cycle 2 Day 1 Pre-dose	351 mcg/mL Standard Deviation 81.3	403 mcg/mL Standard Deviation 143	—
Serum Obinutuzumab Concentration Induction cycle 2 Day 1 Post-dose	616 mcg/mL Standard Deviation 115	672 mcg/mL Standard Deviation 130	—
Serum Obinutuzumab Concentration Induction cycle 4 Day 1 Pre-dose	433 mcg/mL Standard Deviation 322	311 mcg/mL Standard Deviation 177	—
Serum Obinutuzumab Concentration Induction cycle 4 Day 1 Post-dose	583 mcg/mL Standard Deviation 189	619 mcg/mL Standard Deviation 160	—
Serum Obinutuzumab Concentration Induction cycle 6 Day 1 Pre-dose	288 mcg/mL Standard Deviation 123	308 mcg/mL Standard Deviation 194	—
Serum Obinutuzumab Concentration Induction cycle 6 Day 1 Post-dose	514 mcg/mL Standard Deviation 121	605 mcg/mL Standard Deviation 161	—
Serum Obinutuzumab Concentration Maintenance Month 1 Day 1 Pre-dose	221 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.	171 mcg/mL Standard Deviation 131	—
Serum Obinutuzumab Concentration Maintenance Month 7 Pre-dose	90.4 mcg/mL Standard Deviation 58.8	83.8 mcg/mL Standard Deviation 59.6	—
Serum Obinutuzumab Concentration Study drug completion or early discontinuation	—	37.2 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.	—
Serum Obinutuzumab Concentration PK and Immunogenicity follow up	110 mcg/mL Standard Deviation 120	15.4 mcg/mL Standard Deviation 3.20	—

SECONDARY outcome

Timeframe: Pre-dose (0 hr) up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycle 6; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increases every 30 min to maximum of 400 mg/hr)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=21 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Serum Rituximab Concentration Induction Cycle 1 Day 1 Pre-dose	30.4 mcg/mL Standard Deviation 28.8	—	—
Serum Rituximab Concentration Induction Cycle 1 Day 1 Post-dose	197 mcg/mL Standard Deviation 56.9	—	—
Serum Rituximab Concentration Induction Cycle 2 Day 1 Pre-dose	43.5 mcg/mL Standard Deviation 28.7	—	—
Serum Rituximab Concentration Induction Cycle 4 Day 1 Pre-dose	84.8 mcg/mL Standard Deviation 35.7	—	—
Serum Rituximab Concentration Induction Cycle 6 Day 1 Pre-dose	101 mcg/mL Standard Deviation 45.5	—	—
Serum Rituximab Concentration Induction Cycle 6 Day 1 Post-dose	239 mcg/mL Standard Deviation 42.8	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hr) up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 3, 4; pre-dose (within 5 hr) on Day 1 of Cycle 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Month 1; 30 min after EOI on Day 2 of Month 1; pre-dose (within 5 hr) on Day 1 of Month 4, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1-2 years after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=21 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Serum Atezo Concentration Induction Cycle 2 Day 1 Pre-dose	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.
Serum Atezo Concentration Induction Cycle 2 Day 1 Post-dose	332 mcg/mL Standard Deviation 56.7	365 mcg/mL Standard Deviation 80.7	355 mcg/mL Standard Deviation 78.8
Serum Atezo Concentration Induction Cycle 3 Day 1 Pre-dose	86.9 mcg/mL Standard Deviation 28.8	78.7 mcg/mL Standard Deviation 18.4	79.7 mcg/mL Standard Deviation 30.6
Serum Atezo Concentration Induction Cycle 4 Day 1 Pre-dose	139 mcg/mL Standard Deviation 33.1	125 mcg/mL Standard Deviation 47.3	139 mcg/mL Standard Deviation 56.4
Serum Atezo Concentration Induction Cycle 4 Day 1 Post-dose	462 mcg/mL Standard Deviation 82.0	450 mcg/mL Standard Deviation 136	489 mcg/mL Standard Deviation 131
Serum Atezo Concentration Induction Cycle 6 Day 1 Pre-dose	194 mcg/mL Standard Deviation 67.7	181 mcg/mL Standard Deviation 112	180 mcg/mL Standard Deviation 90.6
Serum Atezo Concentration Maintenance Month 1 Day 1 Pre-dose	100 mcg/mL Standard Deviation 66.0	70.7 mcg/mL Standard Deviation 55.5	—
Serum Atezo Concentration Maintenance Month 1 Day 2 Post-dose	577 mcg/mL Standard Deviation 144	473 mcg/mL Standard Deviation 177	—
Serum Atezo Concentration Maintenance Month 4 Pre-dose	240 mcg/mL Standard Deviation 101	140 mcg/mL Standard Deviation 141	—
Serum Atezo Concentration Maintenance Month 7 Pre-dose	226 mcg/mL Standard Deviation 134	221 mcg/mL Standard Deviation 90.5	—
Serum Atezo Concentration Maintenance Month 13 Pre-dose	106 mcg/mL Standard Deviation 83.0	—	—
Serum Atezo Concentration Study drug completion or early discontinuation	—	127 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.	93.0 mcg/mL Standard Deviation 14.2
Serum Atezo Concentration Consolidation Month 1 Day 1 Pre-dose	—	—	132 mcg/mL Standard Deviation 43.3
Serum Atezo Concentration Consolidation Month 1 Day 2 Post-dose	—	—	503 mcg/mL Standard Deviation 214
Serum Atezo Concentration PK and Immunogenicity followup 120D	61.4 mcg/mL Standard Deviation 60.3	16.8 mcg/mL Standard Deviation 26.8	19.9 mcg/mL Standard Deviation 0.778
Serum Atezo Concentration PK and Immunogenicity followup 1 Year	—	NA mcg/mL Standard Deviation NA The mean and standard deviation could not be calculated because they were below the limit of quantification.	—

SECONDARY outcome

Timeframe: Pre-dose (0 hr) up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=21 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Serum Pola Concentration Pre Day 120 Follow-up	—	0.136 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.	2.91 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.
Serum Pola Concentration Induction Cycle 1 Day 1 Pre-dose	—	0.847 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.	35.9 mcg/mL Standard Deviation NA Standard deviation was not estimable because there was only one sample.
Serum Pola Concentration Induction Cycle 2 Day 1 Pre-dose	2.54 mcg/mL Standard Deviation 0.918	2.62 mcg/mL Standard Deviation 1.22	3.37 mcg/mL Standard Deviation 3.60
Serum Pola Concentration Induction Cycle 4 Day 1 Pre-dose	4.73 mcg/mL Standard Deviation 2.10	4.27 mcg/mL Standard Deviation 1.63	4.92 mcg/mL Standard Deviation 2.65
Serum Pola Concentration Maintenance Month 1 Day 1 Pre-dose	1.30 mcg/mL Standard Deviation 0.696	1.63 mcg/mL Standard Deviation 1.75	—
Serum Pola Concentration Study drug completion or early discontinuation	—	—	0.716 mcg/mL Standard Deviation 0.200

SECONDARY outcome

Timeframe: Baseline up to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

Pre-dose (0 hr) on Day 1 of Cycle 1, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab	0 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. (FL cohorts not applicable as rituximab was only administered in the Safety Run- in phase).

Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=21 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Baseline, positive	5.6 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Baseline, negative	94.4 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Induction Cycle 2 Day 1, positive	5.6 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Induction Cycle 2 Day 1, negative	94.4 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Induction Cycle 4 Day 1	100 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Induction Cycle 6 Day 1	100 Percentage of participants	—	—
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab Study drug completion	100 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 35 months

Population: The Safety Evaluable Population for this outcome measure includes participants in the DLBCL cohort who received at least one dose of any study treatment. Participants in the FL 1.4 mg and FL 1.8 mg were not anazlyed.

Pre-dose (0 hr) on Day 1 of Cycle 2, 3, 4, 6, Month 1, 4, 7, 13 and 19, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=21 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 2 Day 1, positive	0 Percentage of participants	0 Percentage of participants	5.3 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 2 Day 1, negative	0 Percentage of participants	0 Percentage of participants	94.7 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 3 Day 1, positive	0 Percentage of participants	0 Percentage of participants	7.1 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 3 Day 1, negative	0 Percentage of participants	0 Percentage of participants	92.9 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 4 Day 1, negative	0 Percentage of participants	0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Induction, Cycle 6 Day 1, negative	0 Percentage of participants	0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Consolidation Month 1 Day 1, negative	0 Percentage of participants	0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Study drug completion, negative	0 Percentage of participants	0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo Atezo PK Immunogenicity Follow up (120D), negative	0 Percentage of participants	0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 35 months

Population: The Safety Evaluable Population that includes patients who received at least one dose of any study treatment.

Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min)

Outcome measures

Outcome measures
Measure	Dose-Escalation FL Cohort 1.4 mg n=3 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 Participants During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-In Phase n=21 Participants For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Percentage of Participants With ATAs to Pola	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

Adverse Events

Dose-Escalation FL Cohort 1.4 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose-Escalation and Expansion FL Cohort 1.8 mg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 2 deaths

Safety Run-in and Expansion DLBCL Cohort

Serious events: 2 serious events

Other events: 15 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Dose-Escalation FL Cohort 1.4 mg n=3 participants at risk During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants.	Dose-Escalation and Expansion FL Cohort 1.8 mg n=10 participants at risk During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.	Safety Run-in and Expansion DLBCL Cohort n=21 participants at risk For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m\^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	20.0% 2/10 • Number of events 2 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/10 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	4.8% 1/21 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
General disorders DEATH	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
General disorders PYREXIA	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Infections and infestations BRONCHOPULMONARY ASPERGILLOSIS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Infections and infestations ERYSIPELAS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Infections and infestations SEPSIS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/10 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	4.8% 1/21 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Investigations C-REACTIVE PROTEIN INCREASED	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Nervous system disorders GUILLAIN-BARRE SYNDROME	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Nervous system disorders LETHARGY	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/10 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	4.8% 1/21 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/10 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	4.8% 1/21 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/3 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	10.0% 1/10 • Number of events 1 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.	0.00% 0/21 • From randomization up to 35 months All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.