Trial Outcomes & Findings for Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated (NCT NCT04778397)

Last Updated: 2025-02-05

Results Overview

OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

258 participants

Primary outcome timeframe

Up to 2.1 years

Results posted on

2025-02-05

Participant Flow

841 participants were screened.

Participants were enrolled at study sites in North America, the United Kingdom, Europe, Asia, and, Australia. 1 participant was enrolled but was not randomized.

Participant milestones

Participant milestones
Measure	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.	Magrolimab + Azacitidine (Non-Intensive Therapy) Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 weekly 30 mg/kg dose; 30 mg/kg every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.
Overall Study STARTED	25	101	104	27
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	25	101	104	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.	Magrolimab + Azacitidine (Non-Intensive Therapy) Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 weekly 30 mg/kg dose; 30 mg/kg every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.
Overall Study Death	9	59	54	11
Overall Study Study Terminated by Sponsor	12	34	42	15
Overall Study Withdrew Consent	1	5	4	1
Overall Study Reason Not Specified	2	1	3	0
Overall Study Lost to Follow-up	1	2	1	0

Baseline Characteristics

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=101 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=104 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) n=27 Participants Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) n=25 Participants Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation up to 32 months. Each cycle was 28 days.	Total n=257 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	23 Participants n=7 Participants	21 Participants n=5 Participants	15 Participants n=4 Participants	78 Participants n=21 Participants
Age, Categorical >=65 years	82 Participants n=5 Participants	81 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	179 Participants n=21 Participants
Age, Continuous	70 years STANDARD_DEVIATION 9.6 • n=5 Participants	71 years STANDARD_DEVIATION 8.0 • n=7 Participants	57 years STANDARD_DEVIATION 9.6 • n=5 Participants	61 years STANDARD_DEVIATION 8.6 • n=4 Participants	68 years STANDARD_DEVIATION 10.0 • n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	43 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants	102 Participants n=21 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	61 Participants n=7 Participants	22 Participants n=5 Participants	14 Participants n=4 Participants	155 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	74 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	195 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	17 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	30 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	72 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	174 Participants n=21 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	17 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment United States	31 Participants n=5 Participants	33 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	65 Participants n=21 Participants
Region of Enrollment Spain	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment France	6 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment United Kingdom	12 Participants n=5 Participants	11 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	26 Participants n=21 Participants
Region of Enrollment Australia	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Japan	8 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Italy	7 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Germany	9 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment Switzerland	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Hong Kong	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Belgium	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Austria	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Sweden	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 2.1 years

Population: Participants from the Intent-to-Treat Analysis (ITT) Set who were appropriate for non-intensive therapy were analyzed. As per the pre-specified analysis, the data in this outcome measure was reported only for the non-intensive therapy groups.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=101 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=104 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy	4.4 months Interval 3.6 to 6.0	6.6 months Interval 4.8 to 8.1	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

Population: Participants from the Intend-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy.

OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=128 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=129 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Overall Survival in All Participants	4.4 months Interval 3.7 to 6.6	6.6 months Interval 4.9 to 8.9	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

EFS: time from randomization to earliest relapse from CR (CR without minimal residual disease (CRMRD-) and CR with MRD positive/MRD unknown (CRMRD+/unk)), treatment failure (failure to achieve CR in 6 months of magrolimab/venetoclax+azacitidine; 2 months after chemotherapy), or death within the response window. 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-). Post-SCT assessments or new AML therapies were included. Date of randomization was assigned as event date for participants with treatment failure. Participants without events were censored at their last assessment. KM estimates were used for analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=128 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=129 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Event-Free Survival (EFS) in All Participants	0.0 months Upper and lower limits of the confidence interval (CI) could not be estimated due to a limitation in the Kaplan-Meier model, as the EFS values were below the level of quantification for this outcome measure.	0.0 months Upper and lower limits of the confidence interval (CI) could not be estimated due to a limitation in the Kaplan-Meier model, as the EFS values were below the level of quantification for this outcome measure.	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

Population: Participants from the Intent-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy.

The rate of CR was the percentage of participants who achieved a CR, including CR without minimal residual disease (CR MRD-) and CR with positive or unknown minimal residual disease (CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on European Leukemia Net (ELN) 2017 AML (ELN 2017 AML) with modifications, while on study prior to initiation of any new anti-AML therapy or stem cell transplant (SCT) within the response assessment window of 2.1 years. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=128 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=129 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Rate of Complete Remission (CR) in All Participants	9.4 percentage of participants Interval 4.9 to 15.8	29.5 percentage of participants Interval 21.8 to 38.1	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

Rate of CR MRD- was the percentage of participants who achieve a CR MRD- within 6 months treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on ELN 2017 AML with modifications, while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 2.1 years. CR MRD- is defined in Outcome Measure #3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=128 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=129 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants	0.8 percentage of participants Interval 0.0 to 4.3	10.1 percentage of participants Interval 5.5 to 16.6	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

The CR+CRh rate was the percentage of participants who achieved a CR (including CR MRD- and CR MRD+/unk) or CRh as defined by CR with partial platelet and absolute neutrophil count (ANC) recovery within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy while on study prior to initiation of any new anti-AML therapy or SCT up to the response assessment window of 2.1 years. CRh is defined as neutrophils \> 0.5 x 10\^9/L; platelets \> 50 x 10\^9/L; bone marrow blasts \< 5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=128 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=129 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Rate of CR and CR With Partial Hematologic Recovery (CR+CRh) in All Participants	10.2 percentage of participants Interval 5.5 to 16.7	34.1 percentage of participants Interval 26.0 to 43.0	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

Population: Participants from the Intent-To-Treat Analysis Set who achieved CR within 6 months in all participants (2 months for participants receiving 7 + 3 chemotherapy) were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy.

DCR was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants 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. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=12 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=38 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Duration of CR (DCR)	9.5 months Interval 2.0 to Upper limit of CI was not estimable due to insufficient number of participants with events.	4.9 months Interval 3.1 to 6.5	—	—

SECONDARY outcome

Timeframe: Up to 2.1 years

Population: Participants from the Intent-To-Treat Analysis Set with who achieved CR+CRh within 6 months in all participants (2 months for participants receiving 7 + 3 chemotherapy) were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy.

Duration of CR+CRh was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) or CRh within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants 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. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/un are defined in Outcome Measure #3. CRh is defined in Outcome Measure #6. KM estimates were used for outcome measure analysis.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=13 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=44 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Duration of CR+CRh	9.5 months Interval 2.0 to Upper limit of CI was not estimable due to insufficient number of participants with events.	4.9 months Interval 3.1 to 6.5	—	—

SECONDARY outcome

Timeframe: First dose date up to 1.3 years plus 70 days

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

TEAEs were defined as any AE that began on or after the date of first dose of study treatment up to the date of last dose of study treatment plus 70 days or the day before initiation of new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=96 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=98 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) n=27 Participants Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) n=23 Participants Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)	96.9 percentage of participants	95.9 percentage of participants	92.6 percentage of participants	95.7 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to 1.3 years plus 70 days

Population: Participants from Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study treatment plus 70 days or the day before initiation of any new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=96 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=98 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) n=27 Participants Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) n=23 Participants Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Percentage of Participants Experiencing Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities	96.9 percentage of participants	99.0 percentage of participants	100 percentage of participants	95.7 percentage of participants

SECONDARY outcome

Timeframe: Predose on Days 1, 4, 8, 11; Days 29 and 57 Predose and 1 hour Postdose; Predose on Days 113, 169, 253, 281 and 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) posttreatment serum concentration of magrolimab. Participants with available data were analyzed.

Outcome measures

Outcome measures
Measure	Magrolimab + Azacitidine (Non-Intensive Therapy) n=88 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Serum Concentration of Magrolimab Day 1 Predose	0.0 μg/mL Standard Deviation 0.0	—	—	—
Serum Concentration of Magrolimab Day 4 Predose	0.0 μg/mL Standard Deviation NA Standard deviation cannot be calculated for 1 participant.	—	—	—
Serum Concentration of Magrolimab Day 8 Predose	0.0 μg/mL Standard Deviation 0.0	—	—	—
Serum Concentration of Magrolimab Day 11 Predose	111 μg/mL Standard Deviation NA Standard deviation cannot be calculated for 1 participant.	—	—	—
Serum Concentration of Magrolimab Day 29 Predose	311 μg/mL Standard Deviation 195	—	—	—
Serum Concentration of Magrolimab Day 29 1 hour Postdose	376 μg/mL Standard Deviation NA Standard deviation cannot be calculated for 1 participant.	—	—	—
Serum Concentration of Magrolimab Day 57 Predose	402 μg/mL Standard Deviation 262	—	—	—
Serum Concentration of Magrolimab Day 57 1 hour Postdose	967 μg/mL Standard Deviation 351	—	—	—
Serum Concentration of Magrolimab Day 113 Predose	138 μg/mL Standard Deviation 96.0	—	—	—
Serum Concentration of Magrolimab Day 169 Predose	198 μg/mL Standard Deviation 129	—	—	—
Serum Concentration of Magrolimab Day 253 Predose	294 μg/mL Standard Deviation 181	—	—	—
Serum Concentration of Magrolimab Day 281 Predose	263 μg/mL Standard Deviation NA Standard deviation cannot be calculated for 1 participant.	—	—	—
Serum Concentration of Magrolimab Day 337 Predose	251 μg/mL Standard Deviation 114	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: 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 + Azacitidine (Non-Intensive Therapy) n=93 Participants Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) n=27 Participants Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Magrolimab + Azacitidine (Intensive Therapy) Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years.	Control Arm: 7+3 Chemotherapy (Intensive Therapy) Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m\^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m\^2 IV push or idarubicin 60 mg/m\^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m\^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days.
Percentage of Participants With Anti-Magrolimab Antibodies	10.4 percentage of participants	11.1 percentage of participants	—	—

Adverse Events

Magrolimab + Azacitidine (Non-Intensive Therapy)

Serious events: 84 serious events

Other events: 92 other events

Deaths: 61 deaths

Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy)

Serious events: 76 serious events

Other events: 94 other events

Deaths: 57 deaths

Magrolimab + Azacitidine (Intensive Therapy)

Serious events: 20 serious events

Other events: 27 other events

Deaths: 14 deaths

Control Arm: 7+3 Chemotherapy (Intensive Therapy)

Serious events: 14 serious events

Other events: 23 other events

Deaths: 10 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