Trial Outcomes & Findings for Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (NCT NCT04599634)

Last Updated: 2025-02-04

Results Overview

Incidence of dose limiting toxicities (i.e., grade and frequency) to determine safety and tolerability were measured by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade is 3 is severe. Grade 4 is life threatening, and Grade 5 is death related to adverse event. A DLT is defined as any grade 3 or higher adverse event that is clinically relevant and deemed probably or definitely related to any of the study drugs or to the combination therapy and occurs during the venetoclax dose-finding period. Exceptions are non-hematologic grade 3 nausea, vomiting or diarrhea. Grade 3 fatigue, electrolyte disturbances, magrolimab or obinutuzumab infusion reactions, and/or grade 3 laboratory abnormalities. Hematologic grade 3 neutropenia, thrombocytopenia, anemia and hemolytic anemia. And/or grade 3 or 4 lymphopenia.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

4 weeks for Arm 1 and 5 weeks for Arm 2

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1, Cohort 1 Follicular Lymphoma Level 1 Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.
Overall Study STARTED	5	6
Overall Study Off Study- Study is Cancelled	5	6
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Treatment: Follicular Lymphoma Dose Expansion Magrolimab intravenous (IV) 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg combination for 2 cycles (28-days each, Cycles -2 and -1), then venetoclax will be added at target dose. Triplet combination treatment with magrolimab/obinutuzumab/venetoclax will be 6 cycles (28-days each, Cycles 1-6); further treatment will be response-adapted. Obinutuzumab administered intravenously, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase. For expansion phase, administered on Days 1, 2, 8 and 15 of Cycle 2 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg. Venetoclax for follicular lymphoma patients in dose finding phase, administered orally at a dose of 600mg or 800mg depending on tolerance, daily, cycles 1-12. For Marginal Zone Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia patients in dose finding phase administered at an escalating dose from 20mg-400mg Cycle 1 on days 1-35, and at a dose of 400mg per day for Cycles 2-12. Patients in expansion phase will receive target dose established from dose finding cohorts daily for all 12 cycles. Magrolimab administered intravenously, starting at 1 mg/kg on second day of first cycle then 30mg/kg on days 8, 15 and 22 of cycle 1 and days 1 and 15 of cycles 2-12 for patients in both the dose finding and expansion phases.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Experimental Treatment: Chronic Lymphocytic Leukemia Dose Expansion Window of magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg loading and maintenance doses + obinutuzumab IV 1000mg combination for two (2) cycles (28-day cycles, Cycles -2 and -1), then venetoclax safety ramp-up to target dose (dose determined from Arm 2) over 5 weeks (35-days, Cycle 1). Triplet combination treatment with magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for 5 additional cycles (28-days each, Cycles 2-6); further treatment will be response-adapted. Obinutuzumab administered intravenously, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.
Overall Study Dose limiting toxicity	0	0	2	0

Baseline Characteristics

Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	69.17 years STANDARD_DEVIATION 7.14 • n=7 Participants	64.27 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks for Arm 1 and 5 weeks for Arm 2

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy Grade 4 Thrombocytopenia Definitely Related	2 Adverse events	0 Adverse events
Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy Grade 3 and 5 Probably and/or Definitely Related Toxicity	0 Adverse events	0 Adverse events

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence, median follow-up of 17.4 months

ORR was determined and reported from individual cohorts and histological diagnosis. ORR was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Complete response is complete resolution of the lesion on imaging. Partial response is 50% or greater reduction in the maximum diameter of the lesion from its original tumor size on imaging. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Overall Response Rate (ORR) (Complete Response + Partial Response) Complete Response	66.7 Percentage of participants Interval 30.0 to 94.1	40 Percentage of participants Interval 7.1 to 76.9
Overall Response Rate (ORR) (Complete Response + Partial Response) Partial Response	16.7 Percentage of participants Interval 0.9 to 56.4	40 Percentage of participants Interval 7.1 to 76.9

SECONDARY outcome

Timeframe: From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 10.9 months.

DOR was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. DOR was measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, death, or, in the absence of progressive disease (PD), date of last assessment. DOR was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Complete response is complete resolution of the lesion on imaging. Partial response is 50% or greater reduction in the maximum diameter of the lesion from its original tumor size on imaging. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Duration of Response (DOR)	NA Months Median and 95% confidence interval cannot be calculated because it was not reached.	17.5 Months Interval 2.8 to Upper confidence interval was not reached

SECONDARY outcome

Timeframe: From the start of the treatment until time of disease relapse, disease progression, alternative anti-lymphoma therapy including radiation, or death, whichever occurs first, up to 20 months

EFS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative anti-lymphoma therapy including radiation, or death, whichever occurs first, measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Event-free Survival (EFS)	NA Months Median and 95% confidence interval cannot be calculated because it was not reached.	20.0 Months Interval 1.5 to Upper confidence interval was not reached.

SECONDARY outcome

Timeframe: From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 13.9 months.

PFS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. PFS was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Progression-free Survival	NA Months Median and 95% confidence interval cannot be calculated because it was not reached.	20.2 Months Interval 1.5 to Upper confidence interval was not reached.

SECONDARY outcome

Timeframe: From the start of the treatment until death from any cause, an average of 15.6 months.

OS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. OS is defined as the time from study enrollment until death from any cause.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Overall Survival (OS)	NA Months Median and 95% confidence interval cannot be calculated because it was not reached because of insufficient number of participants with events (i.e., deaths).	NA Months Median and 95% confidence interval cannot be calculated because it was not reached because of insufficient number of participants with events (i.e., deaths).

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence, an average of 3.3 months.

Population: This outcome measure is applicable to participants with CLL only.

The percentage of participants who are MRD negative was determined by circulating tumor deoxyribonucleic acid (ctDNA) assay after therapy. Negative is undetectable CLL cells on peripheral blood flow cytometry after end of treatment.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Percentage of Participants With Chronic Lymphocytic Leukemia (CLL) With Complete Molecular Remission (MRD Negativity)	—	100 percentage of participants Interval 18.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first study intervention, Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 Participants Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 Participants Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	5 Participants	5 Participants

Adverse Events

Arm 1, Cohort 1 Follicular Lymphoma Level 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 participants at risk Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 participants at risk Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.
Infections and infestations Lung infection	20.0% 1/5 • Number of events 2 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.

Other adverse events

Additional Information

Dr. Mark J. Roschewski

National Cancer Institute

Phone: 240-760-6183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1, Cohort 1 Follicular Lymphoma Level 1 n=5 participants at risk Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase.	Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 n=6 participants at risk Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Injury, poisoning and procedural complications Bruising	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
General disorders Chills	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Number of events 2 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	50.0% 3/6 • Number of events 3 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Nervous system disorders Dizziness	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
General disorders Edema limbs	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Injury, poisoning and procedural complications Fall	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
General disorders Fatigue	40.0% 2/5 • Number of events 2 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	50.0% 3/6 • Number of events 3 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
General disorders Flu like symptoms	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Gastrointestinal disorders Gastrointestinal disorders - Other, Epigastric pain	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Gastrointestinal disorders Gastrointestinal disorders - Other, Reflux	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Nervous system disorders Headache	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Infections and infestations Infections and infestations - Other, SARS-COV-2	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Injury, poisoning and procedural complications Infusion related reaction	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Injury, poisoning and procedural complications Lung infection	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Investigations Neutrophil count decreased	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 4 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Investigations Platelet count decreased	40.0% 2/5 • Number of events 5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	33.3% 2/6 • Number of events 5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 1/5 • Number of events 2 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Infections and infestations Shingles	20.0% 1/5 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	0.00% 0/6 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Infections and infestations Upper respiratory infection	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Renal and urinary disorders Urinary retention	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	33.3% 2/6 • Number of events 2 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
Infections and infestations Urinary tract infection	0.00% 0/5 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.	16.7% 1/6 • Number of events 1 • All-Cause Mortality monitored/assessed an average of 15.6 months, Adverse Events monitored/assessed from Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.