Hematological Malignancies
Conditions
Keywords
CD47
Brief summary
The primary objectives of this study are: * To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS * To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS * To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate
Interventions
DRUGMagrolimab
Administered intravenously
DRUGAzacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Meets the criteria below for the appropriate cohort: * Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) acute myeloid leukemia (AML) or confirmed intermediate, high, or very high risk myelodysplastic syndromes (MDS) that is relapsed, refractory or intolerant to conventional therapy. * Treatment-naive/Unfit Cohorts: Previously untreated individuals with histological confirmation of AML who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen; or previously untreated individuals with intermediate, high, or very high risk MDS. Prior and concurrent therapy with hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed. * Rollover Cohort: Individuals on active magrolimab therapy on the Phase 1 AML (SCI-CD47-002; NCT02678338) trial who are deriving clinical benefit by Investigator assessment. * RBC transfusion dependent low risk MDS cohort: Transfusion-dependent MDS individuals who are very low or low risk by Revised International Prognostic Scoring System (IPSS-R) with previous treatment with an erythroid stimulating agent or lenalidomide. * White blood cell (WBC) count ≤ 20 x 10\^3/mcL * Adequate performance status and hematological, liver, and kidney function. Key
Exclusion criteria
* Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents (with exception of magrolimab for individuals in the Rollover cohort). * Treatment-naive/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine. * Acute promyelocytic leukemia. * Known inherited or acquired bleeding disorders. * Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression. * Clinical suspicion of active central nervous system (CNS) involvement by leukemia. * Known active or chronic hepatitis B or C infection or HIV. * Pregnancy or active breastfeeding. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 4 years | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and before the first date of new anti-cancer therapy including stem-cell transplant (SCT) and/or any AEs leading to premature discontinuation of study drug. |
| Complete Remission (CR) Rate For Participants With AML | Up to 5 years | The CR rate is the percentage of participants who achieved CR without minimal residual disease (CRMRD-), and CR as per European Leukemia Net (ELN) AML recommendations. CRMRD- per ELN was defined as neutrophils ≥1.0 × 10\^9/L; platelets ≥100 × 10\^9/L and \<5% bone marrow blasts. If studied pretreatment, CR with negativity for a genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or similar modality or CR with negativity by multi-color flow cytometry. CR per ELN criteria is 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; MRD positive or unknown. |
| CR Rate for Participants With MDS | Up to 5 years | The CR rate was the percentage of MDS participants who achieved CR per International Working Group (IWG) 2006 criteria. CR per IWG criteria is defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood should have: Hemoglobin (Hgb) ≥11 g/dL, platelets ≥100 × 10\^9/L, neutrophils ≥1.0 × 10\^9/L and blasts 0%. |
| Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS | Up to 8 weeks | RBC transfusion independence was defined by the lack of RBC transfusions for at least an 8 week consecutive period at any time after starting therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of AML Participants With Objective Response Rate (ORR) | Up to 5 years | ORR is the percentage of participants who achieve CR, CR with incomplete hematologic (count) recovery (CRi), CR with partial hematologic (count) recovery (CRh), Partial Response (PR), Morphologic Leukemia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per European Leukemia Net (ELN) AML 2017 recommendations per investigator's evaluation. CR was defined in outcome measure 2. CRi was defined as neutrophils ≥ 1.0 × 10\^9/L or platelets ≥ 100 × 10\^9/L bone marrow blasts \< 5%. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown. CRh was defined in outcome measure 10. PR was defined in outcome measure 8. MLFS was defined as bone marrow blasts \< 5%. Absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; marrow should not merely be aplastic; at least 200 cells should be enumerated or cellularity should be at least 10%. |
| Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants | Up to 5 years | CRh was defined as CR with partial platelet and absolute neutrophil count recovery while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). |
| Duration of Response (DOR) for Participants With AML | Up to 5 years | The DOR was defined as time measurement criteria were met for complete remission (CR) (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR), incomplete blood count recovery (CRi), partial hematologic recovery (CRh), partial remission (PR), marrow CR, or morphologic leukemia-free state (MLFS), whichever was first recorded, until the first date that recurrent or progressive disease, or death with evidence of no disease magrolimab progression is objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR and mCR were defined in outcome measure 7. Marrow CR and PR were defined in outcome measure 8. CRi and MLFS were defined in outcome measure 9. CRh was defined in outcome measure 10. KM estimates were used in the outcome measure analysis. |
| Duration of Response for Participants With MDS | Up to 5 years | The DOR was measured from the time measurement criteria were first met for objective response as assessed by IWG MDS criteria until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented. KM estimates were used in the outcome measure analysis. |
| Overall Survival (OS) for Participants With AML or MDS | Up to 5 years | The length of overall survival will be measured from the date of study treatment initiation until the date of death from any cause. KM estimates were used in the outcome measure analysis. |
| Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up | — |
| Relapse Free Survival (RFS) for Participants With AML or MDS | Up to 5 years | The length of RFS is defined from the first date of attaining a CR (including morphologic CR, CRMRD-, cCR, and mCR) until the date of AML relapse or death from any cause, whichever occurs first. |
| Event Free Survival (EFS) for Participants With AML or MDS | Up to 5 years | For AML, EFS was defined as the time from the date of study treatment initiation until the date of documented disease progression, death from any cause, or treatment failure (defined as failure to achieve CR/CRi/CRh by Cycle 5 Day 1), whichever occurred first. CR/CRi/CRh were defined in outcome measures 2, 9 and 10 respectively. For MDS, EFS was defined as the time from the date of study treatment initiation to transformation to AML or death from any cause, whichever occurred first. Participants who were not observed to have one of these events during the study were censored at their last response assessment date with evidence of no transformation to AML. KM estimates were used in the outcome measure analysis. |
| Change From Baseline in Hemoglobin on Therapy | Baseline and Day 1 | — |
| 12-week RBC Transfusion Independence Rates | Up to 12 Weeks | — |
| Minimal Residual Disease (MRD) Negative Response Rate | Up to 5 years | The MRD-negative response rate was defined as the percentage of participants who reach MRD-negative disease status prior to initiation of other new anti-cancer therapy including SCT and achieve a morphologic CR or marrow CR for MDS participants and achieve CR/CRi/CRh/MLFS for AML participants. MRD-negative disease status will be assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. CR/CRi/MLFS/CRh were defined in outcome measures 2, 9, 10 respectively. Marrow CR was defined in outcome measure 8. |
| Progression Free Survival (PFS) for Participants With AML or MDS | Up to 5 years | The length of PFS is defined as the time from the date of study treatment initiation until the date of documented disease progression (PD) or death from any cause, whichever occurs first. PD for MDS: \<5% blasts: if blasts increase ≥50% to \>5%; 5%-10% blasts: if blasts increase ≥50% to \>10%; 10%-20% blasts: if blasts increase ≥50% to \>20%; 20%-30% blasts: if blasts increase ≥50% to \>30%. Participants with at least 50% decrement from maximum remission/response in granulocytes / platelets or reduction in Hgb by ≥ 2 g/dL or transfusion dependence. PD for AML was defined as any evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: \> 50% increase in marrow blasts over baseline (a minimum 15% point increase is required in cases with \< 30% blasts at baseline; or persistent marrow blast percentage of \>70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count. |
| Percentage of Participants Who Developed Anti-Magrolimab Antibodies | Up to 5 years | As per the pre-specified analysis, this outcome measure was analyzed based on different dosing regimens and timepoints when magrolimab was given alone and in combination with the azacitidine. Therefore, the data is reported for magrolimab as monotherapy and magrolimab plus azacitidine. Also, the arms are based on the frequency of magrolimab administered: QW, Q2W, QW to Q2W, Q4W, BIW and BIW to QW as applicable in different cohorts. |
| Duration of Complete Remission (DCR) in Participants With AML and MDS | Up to 5 years | For AML participants: The DCR was defined as the time measurement criteria were first met for CR (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR) until the first date that recurrent disease or death with evidence of no disease recurrence was objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR was defined as complete disappearance of chromosomal abnormality without appearance of new ones. mCR was defined as morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast. For MDS participants: The DCR was defined as the time measurement criteria were first met for CR until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented. Kaplan-Meier (KM) estimates were used in the outcome measure analysis. |
| Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | Up to 5 years | ORR was the percentage of participants who achieved CR, partial remission (PR), marrow CR or hematological improvement (HI) prior to initiation of a new anticancer therapy including SCT per IWG 2006 criteria per investigator's evaluation. CR was defined in outcome measure 2. PR was defined as all CR criteria if abnormal before treatment except the bone marrow blasts decreased by 50% over pretreatment but still \> 5% and cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤5% myeloblasts and decrease by ≥50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for \> 8 weeks. Percentages were rounded off. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States and the United Kingdom. 1 participant with low-risk MDS was accidentally enrolled High-risk MDS group.
Pre-assignment details
258 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg Participants who were treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 32 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg Participants who were TN with higher risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 63 |
| TN MDS Cohort Low Risk QW 30 mg/kg Participants who were TN with low risk MDS received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 up to end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 1 |
| TN/U AML Cohort: Magrolimab + Azacitidine Participants who were treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) received 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 87 |
| R/R AML Cohort: Magrolimab + Azacitidine Participants with relapsed/refractory (r/r) AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/ kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 19 |
| R/R AML Cohort: Magrolimab Participants with r/r AML received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 6 |
| Rollover AML Cohort: Magrolimab Participants received the same dose level and schedule (30 mg/kg, twice weekly) of magrolimab monotherapy as previously received on the Phase 1 AML study (SCI-CD47-002), or transitioned to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years. | 1 |
| R/R MDS Cohort: Magrolimab + Azacitidine Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 17 |
| R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine Participants with r/r MDS received magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants received azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle (each cycle was of 28 days).
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles. Maximum treatment duration was up to 4 years. | 5 |
| R/R MDS Cohort: Magrolimab Participants with r/r MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years. | 10 |
| Low Risk MDS Cohort: Magrolimab + Azacitidine Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years. | 9 |
| Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants received azacitidine 75 mg/m\^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg.
Participants with r/r MDS who did not have an objective response with magrolimab at the first protocol response assessment had azacitidine added to magrolimab for subsequent cycles. Maximum treatment duration was up to 4 years. | 5 |
| Low Risk MDS Cohort: Magrolimab Participants with low risk MDS received 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day
1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years. | 3 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Consent withdrawn | 6 | 3 | 0 | 9 | 1 | 0 | 0 | 1 | 0 | 3 | 1 | 0 | 1 |
| Overall Study | Death | 12 | 44 | 1 | 72 | 17 | 6 | 1 | 14 | 3 | 7 | 3 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Not reported | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 12 | 15 | 0 | 5 | 0 | 0 | 0 | 1 | 1 | 0 | 5 | 4 | 0 |
Baseline characteristics
| Characteristic | TN MDS Cohort Higher Risk Q2W 30 mg/kg | TN MDS Cohort Low Risk QW 30 mg/kg | TN/U AML Cohort: Magrolimab + Azacitidine | R/R AML Cohort: Magrolimab + Azacitidine | R/R AML Cohort: Magrolimab | Rollover AML Cohort: Magrolimab | R/R MDS Cohort: Magrolimab + Azacitidine | TN MDS Cohort Higher Risk QW 30 mg/kg | R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine | R/R MDS Cohort: Magrolimab | Low Risk MDS Cohort: Magrolimab + Azacitidine | Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Low Risk MDS Cohort: Magrolimab | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 00 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 1 Participants | 70 Participants | 16 Participants | 6 Participants | 1 Participants | 15 Participants | 20 Participants | 5 Participants | 9 Participants | 8 Participants | 5 Participants | 3 Participants | 200 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 0 Participants | 17 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 12 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 58 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 11.6 | 66 years | 71 years STANDARD_DEVIATION 10 | 73 years STANDARD_DEVIATION 7.4 | 77 years STANDARD_DEVIATION 6.3 | 79 years | 72 years STANDARD_DEVIATION 7.2 | 67 years STANDARD_DEVIATION 9.1 | 77 years STANDARD_DEVIATION 1.7 | 73 years STANDARD_DEVIATION 5.3 | 75 years STANDARD_DEVIATION 5.9 | 74 years STANDARD_DEVIATION 7.7 | 79 years STANDARD_DEVIATION 6.4 | 70 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 0 Participants | 81 Participants | 18 Participants | 6 Participants | 1 Participants | 14 Participants | 29 Participants | 5 Participants | 9 Participants | 8 Participants | 5 Participants | 3 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) White | 54 Participants | 0 Participants | 75 Participants | 15 Participants | 5 Participants | 1 Participants | 16 Participants | 31 Participants | 4 Participants | 10 Participants | 6 Participants | 5 Participants | 3 Participants | 225 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Region of Enrollment United States | 63 Participants | 1 Participants | 85 Participants | 19 Participants | 6 Participants | 0 Participants | 17 Participants | 31 Participants | 5 Participants | 10 Participants | 8 Participants | 5 Participants | 3 Participants | 253 Participants |
| Sex: Female, Male Female | 24 Participants | 1 Participants | 37 Participants | 5 Participants | 3 Participants | 1 Participants | 5 Participants | 9 Participants | 4 Participants | 3 Participants | 6 Participants | 1 Participants | 1 Participants | 100 Participants |
| Sex: Female, Male Male | 39 Participants | 0 Participants | 50 Participants | 14 Participants | 3 Participants | 0 Participants | 12 Participants | 23 Participants | 1 Participants | 7 Participants | 3 Participants | 4 Participants | 2 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 32 | 44 / 63 | 1 / 1 | 72 / 87 | 18 / 19 | 6 / 6 | 1 / 1 | 15 / 17 | 3 / 5 | 7 / 10 | 3 / 9 | 1 / 5 | 1 / 3 |
| other Total, other adverse events | 32 / 32 | 60 / 63 | 1 / 1 | 84 / 87 | 19 / 19 | 6 / 6 | 1 / 1 | 17 / 17 | 5 / 5 | 10 / 10 | 9 / 9 | 5 / 5 | 3 / 3 |
| serious Total, serious adverse events | 20 / 32 | 40 / 63 | 0 / 1 | 64 / 87 | 17 / 19 | 4 / 6 | 1 / 1 | 12 / 17 | 2 / 5 | 7 / 10 | 8 / 9 | 3 / 5 | 1 / 3 |
Outcome results
Primary
Complete Remission (CR) Rate For Participants With AML
The CR rate is the percentage of participants who achieved CR without minimal residual disease (CRMRD-), and CR as per European Leukemia Net (ELN) AML recommendations. CRMRD- per ELN was defined as neutrophils ≥1.0 × 10\^9/L; platelets ≥100 × 10\^9/L and \<5% bone marrow blasts. If studied pretreatment, CR with negativity for a genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or similar modality or CR with negativity by multi-color flow cytometry. CR per ELN criteria is 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; MRD positive or unknown.
Time frame: Up to 5 years
Population: Full Analysis Set included participants with AML who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the AML cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Complete Remission (CR) Rate For Participants With AML | 32.2 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Complete Remission (CR) Rate For Participants With AML | 0.0 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Complete Remission (CR) Rate For Participants With AML | 0.0 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Complete Remission (CR) Rate For Participants With AML | 0.0 percentage of participants |
Primary
CR Rate for Participants With MDS
The CR rate was the percentage of MDS participants who achieved CR per International Working Group (IWG) 2006 criteria. CR per IWG criteria is defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood should have: Hemoglobin (Hgb) ≥11 g/dL, platelets ≥100 × 10\^9/L, neutrophils ≥1.0 × 10\^9/L and blasts 0%.
Time frame: Up to 5 years
Population: Full Analysis Set included participants with MDS who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the MDS cohorts.~For the TN MDS Cohort, only participants with higher MDS risk were included for the analyses of this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | CR Rate for Participants With MDS | 37.5 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | CR Rate for Participants With MDS | 30.2 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | CR Rate for Participants With MDS | 0.0 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | CR Rate for Participants With MDS | 0.0 percentage of participants |
| R/R AML Cohort: Magrolimab + Azacitidine | CR Rate for Participants With MDS | 0.0 percentage of participants |
| R/R AML Cohort: Magrolimab | CR Rate for Participants With MDS | 11.1 percentage of participants |
| Rollover AML Cohort: Magrolimab | CR Rate for Participants With MDS | 0.0 percentage of participants |
| R/R MDS Cohort: Magrolimab + Azacitidine | CR Rate for Participants With MDS | 0.0 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and before the first date of new anti-cancer therapy including stem-cell transplant (SCT) and/or any AEs leading to premature discontinuation of study drug.
Time frame: Up to 4 years
Population: Safety Analysis Set included all participants who received ≥ 1 dose of magrolimab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 96.8 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| R/R AML Cohort: Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| R/R AML Cohort: Magrolimab | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Rollover AML Cohort: Magrolimab | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| R/R MDS Cohort: Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| R/R MDS Cohort: Magrolimab | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Low Risk MDS Cohort: Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Low Risk MDS Cohort: Magrolimab | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
Primary
Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS
RBC transfusion independence was defined by the lack of RBC transfusions for at least an 8 week consecutive period at any time after starting therapy.
Time frame: Up to 8 weeks
Population: Full Analysis Set included participants with low-risk MDS who received ≥1 dose of magrolimab. As per the pre-specified analysis, this outcome measure was applicable only for the low risk MDS cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS | 44.4 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS | 40.0 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS | 0.0 percentage of participants |
Secondary
12-week RBC Transfusion Independence Rates
Time frame: Up to 12 Weeks
Population: Data was not collected for this outcome measure.
Secondary
Change From Baseline in Hemoglobin on Therapy
Time frame: Baseline and Day 1
Population: Participants in the Safety Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the R/R AML and TN MDS cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Baseline | 8.5 g/dL | Standard Deviation 1.56 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -0.1 g/dL | Standard Deviation 1.23 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Baseline | 9.0 g/dL | Standard Deviation 1.5 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -0.7 g/dL | Standard Deviation 1.1 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Baseline | 10.1 g/dL | — |
| TN MDS Cohort Low Risk QW 30 mg/kg | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -0.7 g/dL | — |
| TN/U AML Cohort: Magrolimab + Azacitidine | Change From Baseline in Hemoglobin on Therapy | Baseline | 8.8 g/dL | Standard Deviation 1.27 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -0.8 g/dL | Standard Deviation 1.08 |
| R/R AML Cohort: Magrolimab + Azacitidine | Change From Baseline in Hemoglobin on Therapy | Baseline | 9.1 g/dL | Standard Deviation 1.39 |
| R/R AML Cohort: Magrolimab + Azacitidine | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -0.9 g/dL | Standard Deviation 0.92 |
| R/R AML Cohort: Magrolimab | Change From Baseline in Hemoglobin on Therapy | Baseline | 10.3 g/dL | Standard Deviation 1.74 |
| R/R AML Cohort: Magrolimab | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | -1.3 g/dL | Standard Deviation 1.32 |
| Rollover AML Cohort: Magrolimab | Change From Baseline in Hemoglobin on Therapy | Baseline | 8.9 g/dL | — |
| Rollover AML Cohort: Magrolimab | Change From Baseline in Hemoglobin on Therapy | Change at Day 1 | 0.1 g/dL | — |
Secondary
Duration of Complete Remission (DCR) in Participants With AML and MDS
For AML participants: The DCR was defined as the time measurement criteria were first met for CR (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR) until the first date that recurrent disease or death with evidence of no disease recurrence was objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR was defined as complete disappearance of chromosomal abnormality without appearance of new ones. mCR was defined as morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast. For MDS participants: The DCR was defined as the time measurement criteria were first met for CR until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented. Kaplan-Meier (KM) estimates were used in the outcome measure analysis.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with CR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the all AML and TN MDS cohorts.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Duration of Complete Remission (DCR) in Participants With AML and MDS | 14.4 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Duration of Complete Remission (DCR) in Participants With AML and MDS | 8.5 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Duration of Complete Remission (DCR) in Participants With AML and MDS | 9.4 months |
Secondary
Duration of Response (DOR) for Participants With AML
The DOR was defined as time measurement criteria were met for complete remission (CR) (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR), incomplete blood count recovery (CRi), partial hematologic recovery (CRh), partial remission (PR), marrow CR, or morphologic leukemia-free state (MLFS), whichever was first recorded, until the first date that recurrent or progressive disease, or death with evidence of no disease magrolimab progression is objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR and mCR were defined in outcome measure 7. Marrow CR and PR were defined in outcome measure 8. CRi and MLFS were defined in outcome measure 9. CRh was defined in outcome measure 10. KM estimates were used in the outcome measure analysis.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with AML who achieved ORR were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for the AML cohorts.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Duration of Response (DOR) for Participants With AML | 8.7 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Duration of Response (DOR) for Participants With AML | 2.7 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Duration of Response (DOR) for Participants With AML | 2.1 months |
| TN/U AML Cohort: Magrolimab + Azacitidine | Duration of Response (DOR) for Participants With AML | NA months |
Secondary
Duration of Response for Participants With MDS
The DOR was measured from the time measurement criteria were first met for objective response as assessed by IWG MDS criteria until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented. KM estimates were used in the outcome measure analysis.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with TN MDS who achieved ORR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.~As per the pre-specified analysis, this outcome measure was applicable for only TN MDS cohorts.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Duration of Response for Participants With MDS | 12.9 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Duration of Response for Participants With MDS | 9.5 months |
Secondary
Event Free Survival (EFS) for Participants With AML or MDS
For AML, EFS was defined as the time from the date of study treatment initiation until the date of documented disease progression, death from any cause, or treatment failure (defined as failure to achieve CR/CRi/CRh by Cycle 5 Day 1), whichever occurred first. CR/CRi/CRh were defined in outcome measures 2, 9 and 10 respectively. For MDS, EFS was defined as the time from the date of study treatment initiation to transformation to AML or death from any cause, whichever occurred first. Participants who were not observed to have one of these events during the study were censored at their last response assessment date with evidence of no transformation to AML. KM estimates were used in the outcome measure analysis.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.~As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Event Free Survival (EFS) for Participants With AML or MDS | 18.2 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Event Free Survival (EFS) for Participants With AML or MDS | 23.1 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Event Free Survival (EFS) for Participants With AML or MDS | 3.7 months |
| TN/U AML Cohort: Magrolimab + Azacitidine | Event Free Survival (EFS) for Participants With AML or MDS | 1.7 months |
| R/R AML Cohort: Magrolimab + Azacitidine | Event Free Survival (EFS) for Participants With AML or MDS | 1.4 months |
| R/R AML Cohort: Magrolimab | Event Free Survival (EFS) for Participants With AML or MDS | 1.9 months |
Secondary
Minimal Residual Disease (MRD) Negative Response Rate
The MRD-negative response rate was defined as the percentage of participants who reach MRD-negative disease status prior to initiation of other new anti-cancer therapy including SCT and achieve a morphologic CR or marrow CR for MDS participants and achieve CR/CRi/CRh/MLFS for AML participants. MRD-negative disease status will be assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. CR/CRi/MLFS/CRh were defined in outcome measures 2, 9, 10 respectively. Marrow CR was defined in outcome measure 8.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with MDS were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.~As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Minimal Residual Disease (MRD) Negative Response Rate | 28.1 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Minimal Residual Disease (MRD) Negative Response Rate | 20.6 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Minimal Residual Disease (MRD) Negative Response Rate | 21.8 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Minimal Residual Disease (MRD) Negative Response Rate | 5.3 percentage of participants |
| R/R AML Cohort: Magrolimab + Azacitidine | Minimal Residual Disease (MRD) Negative Response Rate | 0.0 percentage of participants |
| R/R AML Cohort: Magrolimab | Minimal Residual Disease (MRD) Negative Response Rate | 0.0 percentage of participants |
Secondary
Overall Survival (OS) for Participants With AML or MDS
The length of overall survival will be measured from the date of study treatment initiation until the date of death from any cause. KM estimates were used in the outcome measure analysis.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Overall Survival (OS) for Participants With AML or MDS | NA months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Overall Survival (OS) for Participants With AML or MDS | 19.4 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Overall Survival (OS) for Participants With AML or MDS | 10.8 months |
| TN/U AML Cohort: Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | 5.2 months |
| R/R AML Cohort: Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | 8.5 months |
| R/R AML Cohort: Magrolimab | Overall Survival (OS) for Participants With AML or MDS | 33.6 months |
| Rollover AML Cohort: Magrolimab | Overall Survival (OS) for Participants With AML or MDS | 8.5 months |
| R/R MDS Cohort: Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | 14.1 months |
| R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | 4.2 months |
| R/R MDS Cohort: Magrolimab | Overall Survival (OS) for Participants With AML or MDS | NA months |
| Low Risk MDS Cohort: Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | NA months |
| Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Overall Survival (OS) for Participants With AML or MDS | 30.6 months |
Secondary
Percentage of AML Participants With Objective Response Rate (ORR)
ORR is the percentage of participants who achieve CR, CR with incomplete hematologic (count) recovery (CRi), CR with partial hematologic (count) recovery (CRh), Partial Response (PR), Morphologic Leukemia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per European Leukemia Net (ELN) AML 2017 recommendations per investigator's evaluation. CR was defined in outcome measure 2. CRi was defined as neutrophils ≥ 1.0 × 10\^9/L or platelets ≥ 100 × 10\^9/L bone marrow blasts \< 5%. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown. CRh was defined in outcome measure 10. PR was defined in outcome measure 8. MLFS was defined as bone marrow blasts \< 5%. Absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; marrow should not merely be aplastic; at least 200 cells should be enumerated or cellularity should be at least 10%.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with AML were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for all AML cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of AML Participants With Objective Response Rate (ORR) | 47.1 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of AML Participants With Objective Response Rate (ORR) | 21.1 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of AML Participants With Objective Response Rate (ORR) | 16.7 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Percentage of AML Participants With Objective Response Rate (ORR) | 0.0 percentage of participants |
Secondary
Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria
ORR was the percentage of participants who achieved CR, partial remission (PR), marrow CR or hematological improvement (HI) prior to initiation of a new anticancer therapy including SCT per IWG 2006 criteria per investigator's evaluation. CR was defined in outcome measure 2. PR was defined as all CR criteria if abnormal before treatment except the bone marrow blasts decreased by 50% over pretreatment but still \> 5% and cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤5% myeloblasts and decrease by ≥50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for \> 8 weeks. Percentages were rounded off.
Time frame: Up to 5 years
Population: Participants with MDS in the Full Analysis Set with data available were analyzed. For the TN MDS Cohort, only participants with higher risk MDS were included. As per the pre-specified analysis, this outcome measure was applicable only the MDS cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 81.3 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 69.8 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 23.5 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 0.0 percentage of participants |
| R/R AML Cohort: Magrolimab + Azacitidine | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 10.0 percentage of participants |
| R/R AML Cohort: Magrolimab | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 33.3 percentage of participants |
| Rollover AML Cohort: Magrolimab | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 40.0 percentage of participants |
| R/R MDS Cohort: Magrolimab + Azacitidine | Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Developed Anti-Magrolimab Antibodies
As per the pre-specified analysis, this outcome measure was analyzed based on different dosing regimens and timepoints when magrolimab was given alone and in combination with the azacitidine. Therefore, the data is reported for magrolimab as monotherapy and magrolimab plus azacitidine. Also, the arms are based on the frequency of magrolimab administered: QW, Q2W, QW to Q2W, Q4W, BIW and BIW to QW as applicable in different cohorts.
Time frame: Up to 5 years
Population: The Immunogenicity Analysis Set included participants in All Enrolled Analysis Set, who took at least 1 dose of magrolimab and have at least 1 anti-drug antibody (ADA) sample result reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| R/R AML Cohort: Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 6.7 percentage of participants |
| R/R AML Cohort: Magrolimab | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 4.7 percentage of participants |
| Rollover AML Cohort: Magrolimab | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 11.1 percentage of participants |
| R/R MDS Cohort: Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 3.9 percentage of participants |
| R/R MDS Cohort: Magrolimab | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| Low Risk MDS Cohort: Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 16.7 percentage of participants |
| Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| Low Risk MDS Cohort: Magrolimab | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 18.2 percentage of participants |
| Low-Risk MDS Cohort: Magrolimab Q4W | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 6.7 percentage of participants |
| Rollover AML Cohort: Magrolimab QW | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
Secondary
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants
CRh was defined as CR with partial platelet and absolute neutrophil count recovery while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT).
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with AML were analyzed. As per the pre-specified analysis, this outcome measure was applicable only for all AML cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants | 0 percentage of participants |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants | 0 percentage of participants |
| TN MDS Cohort Low Risk QW 30 mg/kg | Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants | 0 percentage of participants |
| TN/U AML Cohort: Magrolimab + Azacitidine | Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants | 0 percentage of participants |
Secondary
Progression Free Survival (PFS) for Participants With AML or MDS
The length of PFS is defined as the time from the date of study treatment initiation until the date of documented disease progression (PD) or death from any cause, whichever occurs first. PD for MDS: \<5% blasts: if blasts increase ≥50% to \>5%; 5%-10% blasts: if blasts increase ≥50% to \>10%; 10%-20% blasts: if blasts increase ≥50% to \>20%; 20%-30% blasts: if blasts increase ≥50% to \>30%. Participants with at least 50% decrement from maximum remission/response in granulocytes / platelets or reduction in Hgb by ≥ 2 g/dL or transfusion dependence. PD for AML was defined as any evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: \> 50% increase in marrow blasts over baseline (a minimum 15% point increase is required in cases with \< 30% blasts at baseline; or persistent marrow blast percentage of \>70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included.~As per the pre-specified analysis, this outcome measure was applicable only for all AML and TN MDS cohorts.~KM estimates were used in the outcome measure analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Progression Free Survival (PFS) for Participants With AML or MDS | 14.0 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Progression Free Survival (PFS) for Participants With AML or MDS | 10.7 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Progression Free Survival (PFS) for Participants With AML or MDS | 7.3 months |
| TN/U AML Cohort: Magrolimab + Azacitidine | Progression Free Survival (PFS) for Participants With AML or MDS | 2.6 months |
| R/R AML Cohort: Magrolimab + Azacitidine | Progression Free Survival (PFS) for Participants With AML or MDS | 5.2 months |
| R/R AML Cohort: Magrolimab | Progression Free Survival (PFS) for Participants With AML or MDS | 1.9 months |
Secondary
Relapse Free Survival (RFS) for Participants With AML or MDS
The length of RFS is defined from the first date of attaining a CR (including morphologic CR, CRMRD-, cCR, and mCR) until the date of AML relapse or death from any cause, whichever occurs first.
Time frame: Up to 5 years
Population: Participants in the Full Analysis Set with CR were analyzed. For the TN MDS Cohort, only participants with higher MDS risk were included. As per the pre-specified analysis, this outcome measure was applicable only for the all AML and TN MDS cohorts.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Relapse Free Survival (RFS) for Participants With AML or MDS | 14.4 months |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Relapse Free Survival (RFS) for Participants With AML or MDS | 8.5 months |
| TN MDS Cohort Low Risk QW 30 mg/kg | Relapse Free Survival (RFS) for Participants With AML or MDS | 9.4 months |
Secondary
Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants
Time frame: Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up
Population: The Pharmacokinetic (PK) Analysis Set included participants in All Enrolled Analysis Set, who took at least 1 dose of magrolimab and had at least 1 detectable postdose magrolimab concentration value reported by the PK laboratory at the given timepoint.~As per the pre-specified analysis, this outcome measure was applicable only for the TN/U AML and TN MDS cohorts. Data is reported according to the frequency of magrolimab administered: QW, Q2W, QW to Q2W for both TN/U AML and TN MDS cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.18 ug/mL | Standard Deviation 0.958 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 0.41 ug/mL | Standard Deviation 0.83 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D4 Predose | 0.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D4 1 hour | 0.32 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 254.58 ug/mL | Standard Deviation 53.242 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 Predose | 38.50 ug/mL | Standard Deviation 4.384 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 1 hour | 318.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 320.62 ug/mL | Standard Deviation 166.137 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 778.88 ug/mL | Standard Deviation 268.194 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D16 Predose | 351.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D17 Predose | 278.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D18 Predose | 249.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 416.80 ug/mL | Standard Deviation 131.6 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 1 hour | 873.17 ug/mL | Standard Deviation 217.208 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 398.05 ug/mL | Standard Deviation 251.639 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 807.67 ug/mL | Standard Deviation 419.553 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D2 Predose | 0.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D3 Predose | 0.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D4 Predose | 0.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D4 1 hour | 1.09 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 440.64 ug/mL | Standard Deviation 274.761 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D15 Predose | 294.00 ug/mL | Standard Deviation 213.546 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D22 Predose | 325.50 ug/mL | Standard Deviation 178.898 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 494.00 ug/mL | Standard Deviation 222.682 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 971.76 ug/mL | Standard Deviation 462.426 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C4D1 Predose | 336.00 ug/mL | — |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 673.29 ug/mL | Standard Deviation 183.521 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 1150.50 ug/mL | Standard Deviation 342.217 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 781.83 ug/mL | Standard Deviation 256.528 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 1243.17 ug/mL | Standard Deviation 344.023 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 584.00 ug/mL | Standard Deviation 318.198 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 1290.00 ug/mL | Standard Deviation 608.112 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 298.96 ug/mL | Standard Deviation 203.651 |
| TN MDS Cohort Higher Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 29.36 ug/mL | Standard Deviation 33.138 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 528.31 ug/mL | Standard Deviation 244.068 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 1245.85 ug/mL | Standard Deviation 449.41 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 274.20 ug/mL | Standard Deviation 148.275 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 1 hour | 542.50 ug/mL | Standard Deviation 365.574 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 1063.43 ug/mL | Standard Deviation 445.885 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 301.28 ug/mL | Standard Deviation 143.219 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 Predose | 172.40 ug/mL | Standard Deviation 111.157 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 374.63 ug/mL | Standard Deviation 183.02 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 348.98 ug/mL | Standard Deviation 138.719 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 309.17 ug/mL | Standard Deviation 103.697 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 Predose | 349.50 ug/mL | Standard Deviation 204.719 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 1 hour | 999.00 ug/mL | Standard Deviation 517.85 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 1 hour | 338.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 0.07 ug/mL | Standard Deviation 0.398 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 408.84 ug/mL | Standard Deviation 216.656 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 732.50 ug/mL | Standard Deviation 335.509 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 0.29 ug/mL | Standard Deviation 0.377 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 919.33 ug/mL | Standard Deviation 313.966 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 772.50 ug/mL | Standard Deviation 296.855 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 1 hour | 998.25 ug/mL | Standard Deviation 111.87 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 250.71 ug/mL | Standard Deviation 122.473 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 932.50 ug/mL | Standard Deviation 270.978 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 231.47 ug/mL | Standard Deviation 203.912 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 549.52 ug/mL | Standard Deviation 260.353 |
| TN MDS Cohort Higher Risk Q2W 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 78.26 ug/mL | Standard Deviation 90.758 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 994.86 ug/mL | Standard Deviation 273.703 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 0.19 ug/mL | Standard Deviation 0.218 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 152.00 ug/mL | Standard Deviation 57.983 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 1140.78 ug/mL | Standard Deviation 343.685 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 1297.50 ug/mL | Standard Deviation 310.962 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 948.50 ug/mL | Standard Deviation 88.695 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 578.00 ug/mL | — |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 513.38 ug/mL | Standard Deviation 238.555 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 1 hour | 988.63 ug/mL | Standard Deviation 372.345 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C15D1 Predose | 443.00 ug/mL | — |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 258.43 ug/mL | Standard Deviation 72.514 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 308.33 ug/mL | Standard Deviation 99.219 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 507.50 ug/mL | Standard Deviation 188.883 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 Predose | 422.29 ug/mL | Standard Deviation 315.174 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 1 hour | 1210.00 ug/mL | Standard Deviation 223.756 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 522.56 ug/mL | Standard Deviation 266.403 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 629.56 ug/mL | Standard Deviation 268.028 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 290.82 ug/mL | Standard Deviation 138.712 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 Predose | 422.00 ug/mL | Standard Deviation 174.36 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 458.63 ug/mL | Standard Deviation 156.315 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 390.50 ug/mL | Standard Deviation 104.538 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 237.01 ug/mL | Standard Deviation 109.654 |
| TN MDS Cohort Low Risk QW 30 mg/kg | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 1146.88 ug/mL | Standard Deviation 304.099 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 490.05 ug/mL | Standard Deviation 151.489 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 1016.75 ug/mL | Standard Deviation 131.801 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 360.06 ug/mL | Standard Deviation 115.17 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 1 hour | 1253.33 ug/mL | Standard Deviation 123.423 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 480.74 ug/mL | Standard Deviation 206.793 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 1009.00 ug/mL | Standard Deviation 333.772 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 554.06 ug/mL | Standard Deviation 228.605 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 631.87 ug/mL | Standard Deviation 216.16 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 1306.13 ug/mL | Standard Deviation 396.321 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 611.91 ug/mL | Standard Deviation 411.501 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 666.38 ug/mL | Standard Deviation 317.29 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 1242.99 ug/mL | Standard Deviation 691.574 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C6D1 Predose | 850.00 ug/mL | — |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 628.00 ug/mL | Standard Deviation 504.25 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 1325.33 ug/mL | Standard Deviation 673.298 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 712.50 ug/mL | Standard Deviation 689.429 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 235.96 ug/mL | Standard Deviation 189.895 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.00 ug/mL | Standard Deviation 0 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 16.54 ug/mL | Standard Deviation 76.838 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 1170.50 ug/mL | Standard Deviation 635.689 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 17.39 ug/mL | Standard Deviation 83.188 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 304.36 ug/mL | Standard Deviation 49.765 |
| TN/U AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 Predose | 95.70 ug/mL | — |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 0.40 ug/mL | Standard Deviation 0.615 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 281.01 ug/mL | Standard Deviation 190.602 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 487.42 ug/mL | Standard Deviation 205.862 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 339.06 ug/mL | Standard Deviation 170.95 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 1218.19 ug/mL | Standard Deviation 245.934 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 1 hour | 790.00 ug/mL | Standard Deviation 72.187 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 1 hour | 1367.50 ug/mL | Standard Deviation 343.182 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 Predose | 511.27 ug/mL | Standard Deviation 360.621 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 0.00 ug/mL | Standard Deviation 0 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 349.13 ug/mL | Standard Deviation 93.294 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 1007.87 ug/mL | Standard Deviation 365.807 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 437.63 ug/mL | Standard Deviation 183.664 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 597.71 ug/mL | Standard Deviation 324.158 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 246.76 ug/mL | Standard Deviation 164.42 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 573.62 ug/mL | Standard Deviation 213.474 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.00 ug/mL | Standard Deviation 0 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 311.15 ug/mL | Standard Deviation 307.602 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 106.45 ug/mL | Standard Deviation 198.336 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 1078.64 ug/mL | Standard Deviation 332.665 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 917.67 ug/mL | Standard Deviation 318.951 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 Predose | 370.75 ug/mL | Standard Deviation 138.914 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 293.09 ug/mL | Standard Deviation 75.213 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 1 hour | 1212.88 ug/mL | Standard Deviation 531.496 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 1272.23 ug/mL | Standard Deviation 402.487 |
| R/R AML Cohort: Magrolimab + Azacitidine | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 754.00 ug/mL | Standard Deviation 207.456 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 Predose | 602.77 ug/mL | Standard Deviation 253.499 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 Predose | 495.76 ug/mL | Standard Deviation 352.143 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D8 Predose | 491.43 ug/mL | Standard Deviation 167.348 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C7D1 1 hour | 1039.36 ug/mL | Standard Deviation 312.776 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 1 hour | 968.20 ug/mL | Standard Deviation 249.544 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 1 hour | 887.00 ug/mL | — |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 Predose | 401.78 ug/mL | Standard Deviation 283.485 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C13D1 Predose | 291.67 ug/mL | Standard Deviation 177.293 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 1 hour | 1064.00 ug/mL | Standard Deviation 216.115 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D11 Predose | 189.00 ug/mL | — |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 Predose | 0.00 ug/mL | Standard Deviation 0 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C2D1 Predose | 496.57 ug/mL | Standard Deviation 179.237 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D1 1 hour | 0.77 ug/mL | Standard Deviation 0.696 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 Predose | 545.81 ug/mL | Standard Deviation 332.891 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D22 Predose | 447.93 ug/mL | Standard Deviation 163.772 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 Predose | 0.00 ug/mL | Standard Deviation 0 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C9D1 1 hour | 1036.63 ug/mL | Standard Deviation 313.181 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C11D1 1 hour | 1352.83 ug/mL | Standard Deviation 389.004 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 Predose | 542.00 ug/mL | Standard Deviation 319.484 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | End of Treatment (EOT, Up to 4 years) | 288.39 ug/mL | Standard Deviation 184.303 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C3D1 1 hour | 1062.00 ug/mL | Standard Deviation 328.337 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D15 Predose | 348.64 ug/mL | Standard Deviation 142.833 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C5D1 1 hour | 1104.69 ug/mL | Standard Deviation 488.709 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | Safety Follow-up (FU, Up to 4 years plus 30 days) | 32.97 ug/mL | Standard Deviation 44.045 |
| R/R AML Cohort: Magrolimab | Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants | C1D8 1 hour | 262.54 ug/mL | Standard Deviation 68.001 |