On February 7, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the U.S. Food and Drug Administration (FDA) placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on full clinical hold (Press release, Gilead Sciences, FEB 7, 2024, View Source [SID1234640175]). These decisions follow the recommendation of an independent Data Monitoring Committee which reviewed top-line data from a planned interim analysis of ENHANCE-3 for overall survival (OS). In that analysis, magrolimab in combination with azacitidine plus venetoclax demonstrated futility and an increased risk of death was observed, primarily driven by infections and respiratory failure.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on these results, as well as data from two other clinical studies in higher-risk MDS (ENHANCE) and AML with TP53 mutations (ENHANCE-2) where the primary analyses also demonstrated futility with an increased risk of death in the magrolimab-treatment arm, Gilead will not pursue further development of magrolimab in hematologic cancers.

Patients in the ENHANCE-3 study will discontinue treatment with magrolimab and Gilead is communicating with investigators to determine appropriate next steps for patients in the study. Sub-analyses of ENHANCE-3 for efficacy and safety are ongoing and results will be shared with regulatory authorities and will be submitted for presentation at an upcoming medical meeting and/or publication in a peer-reviewed journal.

Gilead will share a top-line, integrated summary of all pivotal magrolimab trials (ENHANCE, ENHANCE-2 and ENHANCE-3) shortly, as well as more detailed results of each trial in upcoming medical conferences. In addition, Gilead is reviewing the safety of magrolimab across all ongoing solid tumor trials and will provide an update on this assessment as soon as possible.

"The complexity of treating blood cancer is highlighted in these results," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies."

About ENHANCE-3
ENHANCE-3 is a Phase 3 study evaluating the safety and efficacy of magrolimab versus placebo in combination with venetoclax plus azacitidine in newly diagnosed, previously untreated patients with AML who are ineligible for intensive chemotherapy. More information about ENHANCE-3 (NCT05079230) can be found at ClinicalTrials.gov.