While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.
Pictured: Signage at Gilead’s corporate headquarters in Silicon Valley/iStock, Sundry Photography
Gilead Sciences on Thursday suspended patient enrollment in its clinical trials studying the investigational anti-CD47 antibody magrolimab in solid tumors.
The FDA has also placed all solid tumor studies of magrolimab on a partial clinical hold. The halt will affect several Phase II ELEVATE studies, including those in head and neck squamous cell carcinoma, triple-negative breast cancer and colorectal cancer. Enrollment in other investigator-sponsored studies of magrolimab in solid tumors will also be suspended.
Gilead did not give specific reasons for pausing the enrollment but said that it is “reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.”
Patients already enrolled in these studies and who are seeing clinical benefit from treatment may continue to receive magrolimab after reconsenting.
Thursday’s suspension follows the FDA’s directive last week to put a full clinical hold on all studies of magrolimab in myelodysplastic syndromes and acute myeloid leukemia. The full freeze is in line with the recommendations of an Independent Data Monitoring Committee, which reviewed topline data from the ENHANCE-3 study and found that it not only satisfied futility but also demonstrated a heightened risk of death due to infections and respiratory failure.
Magrolimab is a monoclonal antibody designed to target CD47, a cell surface protein that cancer cells exploit to avoid detection by the immune system. By blocking the CD47 pathway, magrolimab can restore the ability of macrophages and other phagocytic cells to eliminate cancer cells. Gilead has often touted this mechanism of action as potentially first-in-class.
However, magrolimab’s development has been difficult, especially in recent months. In July 2023, Gilead announced that it was discontinuing the Phase III ENHANCE trial of magrolimab in myelodysplastic syndromes after a planned analysis of its data satisfied the criteria for futility.
In September 2023, Gilead also terminated the ENHANCE-2 trial for magrolimab in acute myeloid leukemia, similarly for disappointing efficacy signals. A mid-trial independent review found that magrolimab was “unlikely to demonstrate a survival benefit” versus standard of care, the company said at the time.
Gilead also stopped the ENHANCE-3 study of magrolimab for futility.
In August 2023, the FDA placed magrolimab under partial clinical hold, barring enrollment into its acute myeloid leukemia studies, as well as its expanded access program.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
