Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine

Rhea-AI Summary

Gilead Sciences (Nasdaq: GILD) has announced a partial clinical hold on studies evaluating the combination of magrolimab and azacitidine due to suspected unexpected serious adverse reactions (SUSARs). This hold will pause new patient enrollment in the affected studies while current participants can continue receiving treatment. Other magrolimab studies remain unaffected. Gilead is collaborating with regulatory authorities to determine next steps and emphasizes patient safety as a priority.

Positive

• Patients already enrolled in the studies may continue to receive the study medicine.
• Other magrolimab studies not using azacitidine are unaffected.

Negative

• Partial clinical hold on magrolimab plus azacitidine combination studies may delay development timelines.

-- Enrolled Patients in These Studies May Continue Receiving Study Medicine --

-- Studies Outside of Combination with Azacitidine Unaffected --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab.”

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.

The studies impacted by this partial clinical hold include:

• Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
• Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
• Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
• Phase 1b study in MDS (NCT03248479)
• Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts

The studies not impacted include:

• Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
• Phase 2 study in multiple myeloma (NCT04892446)
• Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
• Phase 2 study in solid tumors (NCT04827576)
• Phase 2 study in triple-negative breast cancer (NCT04958785)
• Phase 2 study in colorectal cancer, planned and not currently recruiting

About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.

More information about clinical trials with magrolimab is available at www.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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release 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, including those involving the combination of magrolimab plus azacitidine, and the possibility of unfavorable results from ongoing or additional trials; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not remove the clinical holds on studies evaluating the combination of magrolimab plus azacitidine; 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 factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220125006112/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Marian Cutler, Media

marian.cutler1@gilead.com

Source: Gilead Sciences Inc.

FAQ

What is the reason for the partial clinical hold on Gilead's magrolimab studies?

The FDA placed a partial clinical hold due to an imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) in the study arms.

How many studies are affected by the clinical hold on Gilead's magrolimab?

Several studies, including the Phase 3 ENHANCE studies and others involving the combination with azacitidine, are affected.

Can current patients in the affected Gilead studies continue their treatment?

Yes, patients already enrolled can continue to receive magrolimab and azacitidine or placebo during the hold.

What studies are not impacted by the clinical hold on Gilead's magrolimab?

Studies not involving the combination with azacitidine, such as those in diffuse large B-cell lymphoma and multiple myeloma, remain unaffected.

What are the potential implications for Gilead's stock after this announcement?

The partial clinical hold may create uncertainties regarding timelines for development and commercialization of magrolimab, which could affect investor sentiment.