Gilead Statement on the Discontinuation of Magrolimab Study in AML with TP53 Mutations
Foster City, Calif., September 26, 2023 – Gilead Sciences has stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations. Based on an ad hoc analysis, and following review by an independent data monitoring committee, Gilead concluded that magrolimab is unlikely to demonstrate a survival benefit in AML with TP53 mutations compared to standard of care. There were no new safety signals identified and the safety profile was comparable between treatment arms. ENHANCE-2 is a randomized, open-label, Phase 3 trial to determine if magrolimab plus azacitidine improves overall survival, compared to physician’s choice of venetoclax plus azacitidine or intensive chemotherapy in previously untreated AML with TP53 mutations. Gilead is working with study investigators on appropriate next steps for patients enrolled in this study. This decision follows the previously announced partial clinical hold placed on the ENHANCE-2 study.
Gilead is deeply grateful to the patients, families, investigators, and the advocacy community who participated in this trial and contributed greatly to this research. Investigators have been notified and Gilead is working with them on appropriate next steps for patients enrolled in the study.
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 June 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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