Trial Outcomes & Findings for Study of Magrolimab Combinations in Participants With Myeloid Malignancies (NCT NCT04778410)

Last Updated: 2025-03-20

Results Overview

CR rate was the percentage of participants who achieved CR (CR without minimal residual disease (CRMRD-) or complete remission with positive or unknown minimal residual disease (CRMRD+/unk)) as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-cancer therapy. CRMRD- and CRMRD+/unk were defined as neutrophils \>1.0 ×10\^9/L; platelets \>100 × 10\^9/L and \<5% bone marrow blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRMRD- status as determined using multiparameter flow cytometry with a sensitivity of \< 0.1%. Assessment of leukemia response in participants with acute myeloid leukemia (AML) were conducted based on the European Leukemia Net (ELN) recommendations for AML. Percentages were rounded-off. Clopper-Pearson method was used for outcome measure analysis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-03-20

Participant Flow

77 participants were screened.

Participants were enrolled at study sites in the United States, the United Kingdom and Australia. No participants were enrolled in Cohort 3, so, results are reported only for Cohorts 1 and 2. Due to limited number of participants enrolled, and because all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and Phase 2 Cohorts were combined in outcome measures (OMs) except DLT OM, for which data was collected only in Safety Run-in Cohorts

Participant milestones

Participant milestones
Measure	Safety Run-in Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine Participants in Safety Run-in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Safety Run-in Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) Participants in Safety Run-in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Phase 2 Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine Participants in Phase 2 Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Phase 2 Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) Participants in Phase 2 Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.
Safety Run-in Period STARTED	7	6	0	0
Safety Run-in Period COMPLETED	2	0	0	0
Safety Run-in Period NOT COMPLETED	5	6	0	0
Phase 2 Period STARTED	0	0	11	30
Phase 2 Period COMPLETED	0	0	4	9
Phase 2 Period NOT COMPLETED	0	0	7	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Run-in Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine Participants in Safety Run-in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Safety Run-in Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) Participants in Safety Run-in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Phase 2 Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine Participants in Phase 2 Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Phase 2 Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) Participants in Phase 2 Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.
Safety Run-in Period Death	5	6	0	0
Phase 2 Period Death	0	0	5	18
Phase 2 Period Lost to Follow-up	0	0	1	1
Phase 2 Period Study Terminated By Sponsor	0	0	1	0
Phase 2 Period Withdrew Consent	0	0	0	2

Baseline Characteristics

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run-in Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=7 Participants Participants in Safety Run-in Cohort 1 with untreated AML who were unfit for chemotherapy received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) for 28 days. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28.	Safety Run-in Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=6 Participants Participants in Safety Run-in Cohort 2 with R/R AML received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV for 28 days. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for 28 days.	Phase 2 Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=11 Participants Participants in Phase 2 Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg over 2 hours Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, SC or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Phase 2 Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=30 Participants Participants in Phase 2 Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Total n=54 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION 8.6 • n=5 Participants	47 years STANDARD_DEVIATION 14.9 • n=7 Participants	72 years STANDARD_DEVIATION 4.3 • n=5 Participants	51 years STANDARD_DEVIATION 14.0 • n=4 Participants	58 years STANDARD_DEVIATION 16.1 • n=21 Participants
Age, Customized Age, Categorical · < 50 Years	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants	16 Participants n=21 Participants
Age, Customized Age, Categorical · >= 50 - < 75 Years	3 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	17 Participants n=4 Participants	32 Participants n=21 Participants
Age, Customized Age, Categorical · >= 75 Years	4 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	23 Participants n=4 Participants	43 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants	41 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The Full Analysis Set included all enrolled participants who received at least 1 dose of any study treatment, with treatment group designated according to the assigned treatment. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Complete Remission (CR) Rate (Cohorts 1 and 2)	38.9 percentage of participants Interval 17.3 to 64.3	25 percentage of participants Interval 12.1 to 42.2	—

PRIMARY outcome

Timeframe: Up to 2 years

Population: As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

The minimal residual disease (MRD) negative CR rate was defined as the percentage of participants who maintain CR as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments, as determined using multiparameter flow cytometry with a sensitivity of \< 0.1% while on study prior to initiation of any new anti-AML therapy. Assessment of leukemia response in participants with AML were conducted based on the ELN recommendations for AML. CR was defined in outcome measure #1.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 28 days

Population: The DLT Evaluable Analysis Set included all participants in the Safety Analysis Set who were enrolled in the Safety Run-in cohorts, have safety assessments through the protocol-specified DLT assessment window (first 4 weeks of study dosing, inclusive), and fulfill the criteria for evaluation for DLT specified in the protocol. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

DLTs were defined as any Grade 4 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity (that had worsened in severity from pretreatment baseline) during the 4-week DLT assessment period and was related to magrolimab or magrolimab combination.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=6 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=6 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) (Safety Run-in Cohorts 1, 2 and 3)	0 percentage of participants	0 percentage of participants	—

PRIMARY outcome

Timeframe: First dose date up to 1.7 years plus 70 days

Population: The Safety Analysis Set included all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

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 dosing date or the day before initiation of new anticancer therapy including SCT, whichever comes first. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Cohorts 1, 2 and 3)	100 percentage of participants	97.2 percentage of participants	—

PRIMARY outcome

Timeframe: First dose date up to 1.7 years plus 70 days

Population: Participants in the Safety Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 70 days or the day before initiation of any new anticancer therapy including SCT, whichever comes first. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities (Cohorts 1, 2 and 3)	100 percentage of participants	97.2 percentage of participants	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set were analyzed. Clopper-Pearson exact method was used in outcome measure analysis. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

ORR was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS as per investigator based on prespecified criteria before starting any new anti-AML therapy (including SCT). CRi and CRh were defined as neutrophils \>0.5 x 10\^9/L, platelets \> 50 x 10\^9/L (except residual neutropenia (\<1.0 × 10\^9/L) or thrombocytopenia (\<100 × 109/L) for CRi) and bone marrow blasts \<5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. PR: Neutrophils \>1.0 x 10\^9/L, platelets \>100 x 10\^9/L, bone marrow blasts reduced to 5%-25%, and a ≥50% reduction from baseline. Blasts \<5% with Auer rods may also be considered a PR. MLFS: Bone marrow blasts \<5%, absence of circulating blasts or Auer rods, no extramedullary disease, marrow should not merely be "aplastic"; at least 200 cells or 10% cellularity, and no requirement for hematologic recovery. CR was defined in outcome measure #1. Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Overall Response Rate (ORR)	66.7 percentage of participants Interval 41.0 to 86.7	38.9 percentage of participants Interval 23.1 to 56.5	—

SECONDARY outcome

Timeframe: Up to 2 years

CR/CRh rate was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk) or CRh as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-AML therapy (including SCT). CR was defined in outcome measure 1. CRh was defined in outcome measure 6. Percentages were rounded-off. Clopper-Pearson exact method was used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR/CRh) (Cohorts 1 and 2)	44.4 percentage of participants Interval 21.5 to 69.2	30.6 percentage of participants Interval 16.3 to 48.1	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set who achieved overall response were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

DOR was measured from the time assessment criteria that were met for CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS, whichever was first recorded, until the first date of AML relapse, progressive disease, or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies.CR was defined in outcome measure #1. CRi, CRh, PR, or MLFS were defined in outcome measure #6. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=12 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=14 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Duration of Response (DOR) (Cohorts 1 and 2)	15.9 months Interval 2.2 to Upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.	8.7 months Interval 6.3 to Upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set who achieved CR were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

DCR was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=7 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=9 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Duration of Complete Remission (DCR) (Cohorts 1 and 2)	15.9 months Interval 6.7 to Upper limit of CI was not estimable due to insufficient number of participants with events.	8.7 months Interval 2.3 to Upper limit of CI was not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set who achieved CR/CRi were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

Duration of CR/CRi was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) or CRi until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRi was defined in outcome measure #6. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=9 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=11 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Duration of CR/CRi (Cohorts 1 and 2)	15.9 months Interval 3.9 to Upper limit of CI was not estimable due to insufficient number of participants with events.	8.7 months Interval 2.3 to Upper limit of CI was not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set who achieved CR/CRh were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose.

Duration of CR/CRh was measured from the time the assessment criteria are first met for CR (CRMRD- or CRMRD+/unk) or CRh until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRh was defined in outcome measure #6. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=8 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=11 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Duration of CR/CRh (Cohorts 1 and 2)	15.9 months Interval 6.7 to Upper limit of CI was not estimable due to insufficient number of participants with events.	8.7 months Interval 2.3 to Upper limit of CI was not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 2 years

EFS was defined as the time from the date of the first dose of study treatment to the earliest date of documented relapse from CR, treatment failure (defined as failure to achieve CR during the response assessment window (the first treatment dosing date until before the fifth cycle of magrolimab + venetoclax + azacitidine in Cohort 1 and the first treatment dosing date until before the third cycle of magrolimab + MEC in Cohort 2), or death from any cause within the response assessment window. Response assessments post SCT were included in the analysis. Deaths post SCT or new anti-AML therapies (except SCT and post SCT maintenance) were included. Those who were not observed to have one of these events during the study were censored at the date of their last response assessment during the study. Day 1 of treatment was assigned as the event date for participants with treatment failure. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Event-Free Survival (EFS) (Cohorts 1 and 2)	3.8 months Interval 0.0 to 16.8	0.0 months Upper and lower limits of the CI could not be estimated due to a limitation in the Kaplan-Meier model, as EFS values were below the level of quantification for this outcome measure.	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

RFS was defined as the time from the first dose of study treatment until the first date of AML relapse or death from any cause, whichever came first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: As no participants were enrolled in Cohort 3, data were not collected for this outcome measure.

MRD negative CR/CRi rate was defined as the percentage of participants who maintained CR/CRi as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments as determined using multiparameter flow cytometry with a sensitivity of \< 0.1% while on study prior to initiation of any new anti-AML therapy. CR was defined in outcome measure #1. CRi was defined in outcome measure #6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

Duration of MRD negative CR was measured from the time the participant achieved MRD-negative status and maintained CR until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: As no participants were enrolled in Cohort 3, data were not collected for this outcome measure.

Duration of MRD negative CR/CRi was measured from the time the participant achieved MRD-negative status (first of the 2 consecutive MRD negative bone marrow assessments) and maintained CR/CRi until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1. CRi was defined in outcome measure #6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

OS was measured from the date of the first dose of study treatment to the date of death from any cause. Those who were not observed to die during the study were censored at last date they were known to be alive. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Overall Survival (OS) (Cohorts 1, 2 and 3)	15.3 months Interval 3.1 to Upper limit of CI was not estimable due to insufficient number of participants with events.	10.5 months Interval 7.1 to 15.4	—

SECONDARY outcome

Timeframe: Up to 2 years

RBC transfusion independence rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusion at any time between the date of the first dose and discontinuation of study treatment among all participants who were RBC transfusion-dependent at baseline. RBC transfusion independence rate was reported as 2 categories: 1. Conversion rate: Participants who received an RBC or whole blood transfusion within the 28 days prior to the first dose of study treatment, and were RBC transfusion-independent post-baseline. 2. Maintenance rate: Participants who were RBC transfusion independent at baseline and maintained it post-baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Red Blood Cell (RBC) Transfusion Independence Rate (Cohorts 1, 2 and 3) RBC Transfusion Independence (Conversion) Rate	30.8 percentage of participants Interval 9.1 to 61.4	3.8 percentage of participants Interval 0.1 to 19.6	—
Red Blood Cell (RBC) Transfusion Independence Rate (Cohorts 1, 2 and 3) RBC Transfusion Independence (Maintenance) Rate	60.0 percentage of participants Interval 14.7 to 94.7	20.0 percentage of participants Interval 2.5 to 55.6	—

SECONDARY outcome

Timeframe: Up to 2 years

Platelet transfusion independence 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 and discontinuation of study treatment among all participants who were platelet transfusion-dependent at baseline. Platelet transfusion independence rate was reported as 2 categories: 1. Conversion rate: Participants who received an platelet transfusion within 28 days prior to the first dose of study treatment, 2. Maintenance rate: Participants who were platelet transfusion independent at baseline and maintained it post-baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=18 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=36 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Platelet Transfusion Independence Rate (Cohorts 1, 2 and 3) Platelet Transfusion Independence (Conversion) Rate	0.0 percentage of participants Interval 0.0 to 70.8	8.7 percentage of participants Interval 1.1 to 28.0	—
Platelet Transfusion Independence Rate (Cohorts 1, 2 and 3) Platelet Transfusion Independence (Maintenance) Rate	60.0 percentage of participants Interval 32.3 to 83.7	7.7 percentage of participants Interval 0.2 to 36.0	—

SECONDARY outcome

Timeframe: Cohort 1: Predose: Days 1, 8, 29, 57, 113, 169, 253 and 337; Cohort 2: Days 1, 8, 29 and 57

Population: The Pharmacokinetic Analysis Set included all enrolled participants who received at least 1 dose of magrolimab and 1 measurable (non-below the limit of quantitation numeric values) post-treatment serum concentration of magrolimab. Participants with available data were analyzed. Per pre-specified analysis, arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=13 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=25 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 1	0.0 μg/mL Standard Deviation 0.0	0.0 μg/mL Standard Deviation 0.0	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 8	0.0 μg/mL Standard Deviation 0.0	0.0 μg/mL Standard Deviation 0.0	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 29	376 μg/mL Standard Deviation 271	507 μg/mL Standard Deviation 272	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 57	1050 μg/mL Standard Deviation 925	824 μg/mL Standard Deviation 581	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 113	648 μg/mL Standard Deviation 314	—	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 169	592 μg/mL Standard Deviation 371	—	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 253	178 μg/mL Standard Deviation 166	—	—
Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) Predose: Day 337	337 μg/mL Standard Deviation NA Standard deviation could not be calculated for 1 participant.	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of magrolimab and have at least 1 reported anti-magrolimab antibody test result. Participants with post-baseline data were analyzed. Per pre-specified analysis, arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected.

Percentages were rounded-off.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=14 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=26 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Percentage of Participants With Anti-Magrolimab Antibodies (Cohorts 1 and 2)	0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participants in the Immunogenicity Analysis Set with post-baseline data were analyzed. Per Specified analysis, the arms for both Cohorts 1 and 2 for Safety Run-in and Phase 2 periods were combined for analysis. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine n=14 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m\^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years.	Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) n=26 Participants Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m\^2 IV, etoposide 100 mg/m\^2 IV and cytarabine 1000 mg/m\^2 IV on Days 1 to 5 for three 28-day cycles.	Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given.
Levels of Anti-Magrolimab Antibodies (Cohorts 1 and 2)	NA titer ADA levels could not be analyzed as there were no positive samples available for analysis.	NA titer ADA levels could not be analyzed as there were no positive samples available for analysis.	—

Adverse Events

Cohort 1 (1L, Unfit AML): Safety Run-In Cohort: Magrolimab + Venetoclax + Azacitidine

Serious events: 7 serious events

Other events: 7 other events

Deaths: 5 deaths

Cohort 2 (R/R AML): Safety Run-In Cohort: Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Cohort 1 (1L, Unfit AML): Phase 2 Cohort: Magrolimab + Venetoclax + Azacitidine

Serious events: 11 serious events

Other events: 11 other events

Deaths: 5 deaths

Cohort 2 (R/R AML): Phase 2: Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine)

Serious events: 18 serious events

Other events: 29 other events

Deaths: 19 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