Setbacks Mount for Gilead’s Magrolimab Trials as FDA Enforces Partial Hold

In a chain of unfolding events reminiscent of the tumbling of dominos, Gilead Sciences, a leading player in the biotech industry, finds itself confronted with yet another formidable challenge. Merely a week after disclosing concerning adverse events among blood cancer patients, the esteemed biotech firm has made the decision to halt the enrollment of magrolimab solid tumor trials.

 This course of action was prompted by a request from the FDA for a partial clinical hold on the anti-CD47 monoclonal antibody, adding a layer of complexity to the drug’s development journey.

This partial hold casts a shadow over four ongoing phase 2 studies sponsored by Gilead, all meticulously designed to evaluate magrolimab’s efficacy in patients grappling with solid tumors, encompassing diverse types such as colorectal and triple-negative breast cancers. Patients currently deriving benefits from magrolimab treatment have been offered the option to re-consent, providing them with the opportunity to continue receiving the antibody under careful supervision.

In response to these recent developments, Gilead has launched a comprehensive review of the benefit-risk profile associated with magrolimab across all ongoing trials. This evaluation aims to shed light on the potential implications of the FDA’s partial clinical hold and to guide future decision-making regarding the drug’s development pathway. The company has pledged to provide updates on the outcomes of this assessment in a timely manner, ensuring transparency and accountability in its endeavors.

This decision comes hot on the heels of Gilead’s recent announcement to discontinue further development of magrolimab in the context of blood cancer, a move driven by discouraging futility analyses and an increased mortality risk observed in clinical trials. 

Dr. Merdad Parsey, Gilead’s Chief Medical Officer, previously remarked on the challenges associated with treating blood cancer, emphasizing the complexities inherent in navigating such clinical landscapes. However, the latest events underscore that the pursuit of addressing solid tumors poses an equally formidable challenge for Gilead and its investigational asset, magrolimab.

The trajectory of magrolimab since its acquisition by Gilead has been fraught with a litany of setbacks and hurdles. Initially acquired with the strategic aim of diversifying Gilead’s blood cancer pipeline, magrolimab’s journey has been marked by notable challenges, culminating in failed phase 3 trials and adverse patient outcomes. 

Despite Gilead’s successful navigation through a partial clinical hold earlier in 2022, subsequent months have brought forth more substantial obstacles, highlighting the inherent uncertainties and risks associated with drug development endeavors.

These setbacks extend beyond the confines of Gilead and magrolimab, reflecting broader shifts in sentiment and investment patterns surrounding CD47-targeting therapies. Despite initial enthusiasm from Gilead, AbbVie, Pfizer, and other industry players, investments in CD47-targeting therapies have dwindled significantly in recent times. 

Solid tumors had represented hope for CD47-targeting therapies, as evidenced by ALX Oncology’s successful phase 2 trial last year. Despite encountering setbacks in previous blood cancer trials, ALX Oncology remains resolute in its pursuit and plans to initiate a phase 3 study in gastric cancer later this year. Nevertheless, the trajectory of Gilead’s pursuit in this domain remains shrouded in uncertainty, with the future direction of magrolimab’s development hanging in the balance.

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