Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

A phase 3 trial of Magrolimab and Azacitidine in Myelodysplastic syndromes / neoplasms, run by Gilead Sciences, recorded as terminated on the registry.

Also called: ENHANCE

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) is a phase 3 interventional study registered as NCT04313881 by Gilead Sciences, with 539 participants recorded, started 2020-09-09 and due to reach its primary completion in 2023-09-13. Interventions recorded: Magrolimab, Azacitidine, Placebo. Conditions recorded: Myelodysplastic Syndromes.

Linked to the drug Magrolimab because the registry names it among its interventions and Myelodysplastic syndromes / neoplasms among its conditions. Registry record only: no result has been read by an editor.

Setting

ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

Phase

Phase 3

Sponsor

Gilead Sciences

Registry

Started

2020-09-09

Reported

2024

Enrolled

539 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

539 enrolled

Percentage of Participants With Complete Remission (CR)primarysurrogate endpoint

21.3 vs 23.6 out of 100 had no sign of cancer on scans or tests with Magrolimab + Azacitidine compared with Placebo + Azacitidine; 2.3 fewer per 100.
On this measure the first group did worse, not better.

The p-value (0.5218) means the difference could plausibly be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Overall Survival (OS)primarysurvival endpoint

Median 15.9 vs 18.6 months with Magrolimab + Azacitidine compared with Placebo + Azacitidine; about 2.7 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 20 percent higher chance of the event at any given time (hazard ratio 1.203, likely range 0.947 to 1.528).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Progression Free Survival (PFS)surrogate endpoint

Median 9 vs 9.4 months with Magrolimab + Azacitidine compared with Placebo + Azacitidine; about 0.4 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 2 percent higher chance of the event at any given time (hazard ratio 1.02, likely range 0.802 to 1.297).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Objective Response Rate (ORR)response endpoint

53.7 vs 58.7 out of 100 had their tumour shrink with Magrolimab + Azacitidine compared with Placebo + Azacitidine; 5 fewer per 100.
On this measure the first group did worse, not better.

The p-value (0.2563) means the difference could plausibly be due to chance.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

539 enrolled.

Percentage of Participants With Complete Remission (CR)primary

· p = 0.5218

Magrolimab + Azacitidine21.3 of 100

n = 268

Placebo + Azacitidine23.6 of 100

n = 271

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95% CI 16.5 to 26.7; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication · 95% CI 18.7 to 29.1

Overall Survival (OS)primary

HR 1.203 (0.947 to 1.528) · p = 0.1299

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95% CI 13.3 to 19.5; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication · 95% CI 14.9 to 26.2

Progression Free Survival (PFS)

HR 1.02 (0.802 to 1.297) · p = 0.8720

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95% CI 8.3 to 10.9; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication · 95% CI 8.6 to 11.4

Objective Response Rate (ORR)

· p = 0.2563

Magrolimab + Azacitidine53.7 of 100

n = 268

Placebo + Azacitidine58.7 of 100

n = 271

Download

95% CI 47.6 to 59.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication · 95% CI 52.6 to 64.6

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Percentage of Participants With Complete Remission (CR)primary	Magrolimab + Azacitidine	268	21.3%	-	0.5218	link
	Placebo + Azacitidine	271	23.6%	-	0.5218	link
Overall Survival (OS)primary	Magrolimab + Azacitidine	268	15.9 months	1.203 (0.947 to 1.528)	0.1299	link
Overall Survival (OS)primary	Placebo + Azacitidine	271	18.6 months	1.203 (0.947 to 1.528)	0.1299	link
Progression Free Survival (PFS)	Magrolimab + Azacitidine	268	9 months	1.02 (0.802 to 1.297)	0.8720	link
Progression Free Survival (PFS)	Placebo + Azacitidine	271	9.4 months	1.02 (0.802 to 1.297)	0.8720	link
Objective Response Rate (ORR)	Magrolimab + Azacitidine	268	53.7%	-	0.2563	link
Objective Response Rate (ORR)	Placebo + Azacitidine	271	58.7%	-	0.2563	link

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cancers

Higher-risk myelodysplastic syndromes Myelodysplastic syndromes / neoplasms (MDS)

drugs

ApprovedSmall-molecule hypomethylating agent (cytotoxic)

Azacitidine · Vidaza / Onureg (oral)

WithdrawnMonoclonal antibody (anti-CD47)

companies

Gilead Sciences (incl. Kite)