Gilead Statement on Discontinuation of Phase 3 ENHANCE-3 Study in AML
– Magrolimab in Combination with Venetoclax Plus Azacitidine Demonstrated Futility and an Increased Risk of Death in Patients with AML –
– FDA Places Full Clinical Hold on All Magrolimab AML and MDS Studies, Including Expanded Access Programs –
Foster City, Calif., February 7, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced 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. 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.
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.”
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.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead Forward-Looking Statements
This statement includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving magrolimab; uncertainties relating to regulatory applications and related filing and approval timelines; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
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