Trial Outcomes & Findings for Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (NCT NCT05079230)

Last Updated: 2025-04-04

Results Overview

OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

378 participants

Primary outcome timeframe

Up to 1.6 years

Results posted on

2025-04-04

Participant Flow

502 participants were screened.

Participants were enrolled at study sites in Asia, Europe, North America and Australia.

Participant milestones

Participant milestones
Measure	Magrolimab + Venetoclax + Azacitidine Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Overall Study STARTED	189	189
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	189	189

Reasons for withdrawal

Reasons for withdrawal
Measure	Magrolimab + Venetoclax + Azacitidine Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Overall Study Study Terminated by Sponsor	101	102
Overall Study Death	72	66
Overall Study Withdrew Consent	16	18
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Total n=378 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION 7.0 • n=5 Participants	74 years STANDARD_DEVIATION 8.0 • n=7 Participants	74 years STANDARD_DEVIATION 7.5 • n=5 Participants
Age, Customized < 75 Years	93 Participants n=5 Participants	91 Participants n=7 Participants	184 Participants n=5 Participants
Age, Customized >= 75 Years	96 Participants n=5 Participants	98 Participants n=7 Participants	194 Participants n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	83 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	106 Participants n=7 Participants	222 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants	149 Participants n=7 Participants	298 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	28 Participants n=7 Participants	50 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	26 Participants n=5 Participants	25 Participants n=7 Participants	51 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	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	130 Participants n=7 Participants	260 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Hong Kong	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Hungary	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Czechia	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Switzerland	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Spain	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Austria	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Netherlands	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment South Korea	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Belgium	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Norway	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Taiwan	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Poland	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Italy	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Israel	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Australia	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment France	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Germany	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-to-Treat Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Overall Survival (OS)	10.7 months Interval 8.7 to 14.9	14.1 months Interval 9.7 to Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-to-Treat analysis set were analyzed.

The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils \>1.0 ×10\^9/L, platelets \>100 ×10\^9/L, \<5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry \<0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)	47.6 percentage of participants Interval 40.3 to 55.0	53.4 percentage of participants Interval 46.1 to 60.7

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Rate of Complete Remission (CR)	41.3 percentage of participants Interval 34.2 to 48.6	46.0 percentage of participants Interval 38.8 to 53.4

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. KM estimates were used in outcome measure analysis. CR is defined in outcome measure 2.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Event-Free Survival (EFS)	0.0 months Interval 0.0 to 5.4	1.7 months Interval 0.0 to 4.5

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set who achieved CR + CRh within 6 cycles were analyzed. Each cycle was of 28 days.

The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=90 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=101 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)	9.4 months Interval 5.9 to Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.	9.2 months Interval 5.8 to Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set who achieved CR within 6 cycle in all participants were analyzed. Each cycle was of 28 days.

The DCR was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=78 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=87 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR)	9.4 months Interval 6.3 to Upper limit of CI was not estimable due to low number of participants with events.	8.1 months Interval 5.7 to Upper limit of CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils \> 0.5 x 10\^9/L; platelets \> 50 x 10\^9/L; bone marrow blasts \< 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of \< 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-)	24.3 percentage of participants Interval 18.4 to 31.1	22.2 percentage of participants Interval 16.5 to 28.8

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD is defined in outcome measure #2. Each cycle was of 28 days. Percentages were rounded off

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Rate of CR Without Minimal Residual Disease (CRMRD-)	21.7 percentage of participants Interval 16.0 to 28.3	20.1 percentage of participants Interval 14.6 to 26.5

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set with RBC transfusion dependence at Baseline were analyzed.

The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=151 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=151 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Red Blood Cell (RBC) Transfusion Independence Conversion Rate	51.7 percentage of participants Interval 43.4 to 59.9	58.3 percentage of participants Interval 50.0 to 66.2

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set with Platelet transfusion dependence at Baseline were analyzed.

The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=74 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=74 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Platelet Transfusion Independence Conversion Rate	48.6 percentage of participants Interval 36.9 to 60.6	47.3 percentage of participants Interval 35.6 to 59.3

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

The TTD on the EORTC QLQ-C30 GHS/QoL scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever was earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale meant better GHS/QoL. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale	4.7 months Interval 2.3 to 6.3	5.1 months Interval 2.8 to 6.9

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Participants in the Intent-To-Treat Analysis Set were analyzed.

The TTD on the EORTC QLQ-C30 physical functioning scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale	3.0 months Interval 2.1 to 4.4	3.9 months Interval 2.8 to 6.9

SECONDARY outcome

Timeframe: First dose date up to 1.4 years plus 70 days

Population: The Safety Analysis Set included all participants who received at least 1 dose of any study treatment, with treatment assignments designated according to the actual treatment received.

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anti-AML therapy including stem cell transplantation, whichever is earlier. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=184 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	99.5 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to 1.4 years, plus 70 days

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 70 days or the day before the initiation of new anti-AML therapy including SCT, whichever came first, and were summarized by treatment group. Severity grades were defined by the CTCAE Version 5.0. 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-Threatening; 5 = Death. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=189 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine n=184 Participants Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities	99.5 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Predose on Day 1, Day 8, Day 15, Day 29; Predose on Day 57 and 1 hour post-dose; Predose on Day 113, Day 169, Day 253, and Day 337.

Population: The Pharmacokinetic (PK) Analysis Set included all randomized participants who took at least one dose of magrolimab and have at least 1 measurable (non - below the limit of quantitation (BLQ) numeric values) post-treatment serum concentration of magrolimab with data available for analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=156 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Serum Concentration of Magrolimab Over Time Day 1 Predose	0 µg/mL Standard Deviation 0	—
Serum Concentration of Magrolimab Over Time Day 8 Predose	0 µg/mL Standard Deviation 0	—
Serum Concentration of Magrolimab Over Time Day 15 Predose	291 µg/mL Standard Deviation 123	—
Serum Concentration of Magrolimab Over Time Day 29 Predose	385 µg/mL Standard Deviation 206	—
Serum Concentration of Magrolimab Over Time Day 57 Predose	503 µg/mL Standard Deviation 230	—
Serum Concentration of Magrolimab Over Time Day 57, 1 h Postdose	1060 µg/mL Standard Deviation 289	—
Serum Concentration of Magrolimab Over Time Day 113 Predose	281 µg/mL Standard Deviation 140	—
Serum Concentration of Magrolimab Over Time Day 169 Predose	274 µg/mL Standard Deviation 120	—
Serum Concentration of Magrolimab Over Time Day 253 Predose	322 µg/mL Standard Deviation 151	—
Serum Concentration of Magrolimab Over Time Day 337 Predose	298 µg/mL Standard Deviation 72.9	—

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: The participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all randomized participants who received at least one dose of magrolimab and had at least one evaluable anti-magrolimab antibody test result.

Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=166 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Percentage of Participants With Anti-Magrolimab Antibodies	2.4 percentage of participants	—

SECONDARY outcome

Timeframe: Up to 1.6 years

Population: Data is reported for participants in the Immunogenicity Analysis Set with quantifiable measurement for ADA for magrolimab.

Outcome measures

Outcome measures
Measure	Magrolimab + Venetoclax + Azacitidine n=4 Participants Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.	Magrolimab Matching Placebo + Venetoclax + Azacitidine Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m\^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
Maximum Levels of Serum Anti-Magrolimab Antibodies	40 titer Standard Deviation 67.33	—

Adverse Events

Magrolimab + Venetoclax + Azacitidine

Serious events: 138 serious events

Other events: 180 other events

Deaths: 84 deaths

Magrolimab Matching Placebo + Venetoclax + Azacitidine

Serious events: 134 serious events

Other events: 179 other events

Deaths: 70 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER