Gilead Halts Global Magrolimab Trials in Solid Tumors Following FDA Clinical Hold

Feb 17, 2024 05:41 CST Updated 05:41

Gilead Sciences

Antiviral Drug Developer

On February 15, Gilead Sciences announced that it had suspended its CD47 monoclonal antibody magrolimab in solid tumor studies worldwide. This trial suspension follows a request from the FDA a week prior to halt all magrolimab studies for myelodysplastic syndromes (MDS) and AML (including related expanded access programs) (see:Gilead Terminates Development of All CD47 Antibody Hematological Tumor Projects）。

Gilead-sponsored ELEVATE solid tumor studies affected by partial clinical holds include:

Phase II Study for the Treatment of Squamous Cell Carcinoma of the Head and Neck (NCT04854499）；
TreatmentSolid TumorIIPhase Research（NCT04827576）；
TreatmentTriple-Negative Breast CancerTheIIPhase Research（NCT04958785）；
TreatmentColorectal CancerIIPhase Research（NCT05330429）

Gilead stated that it is reviewing the benefit-risk of all ongoing trials and will provide an update on this assessment as soon as possible. Patients who have already participated in the ELEVATE solid tumor study and achieved clinical benefit can continue to choose to receive magrolim.AB Therapy.

The CD47 target, represented by magrolimab, was once considered the birthplace of the next blockbuster. However, the development of drugs for this target has not been smooth. After the failure in developing treatments for hematologic malignancies, Gilead Sciences pinned its hopes on solid tumors. Now, with the FDA placing a clinical hold on the drug, this is undoubtedly adding insult to injury for Gilead Sciences.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position.For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.