What's Happening?
Allogene Therapeutics has decided to discontinue the use of its monoclonal antibody, ALLO-647, following a patient death in its Phase II ALPHA3 trial for large B-cell lymphoma. The death was attributed to liver failure caused by disseminated adenovirus infection in the context of immune suppression, linked to ALLO-647. The company will now proceed with using fludarabine and cyclophosphamide as lymphodepletion treatments for patients receiving cemacabtagene ansegedleucel, an investigative CAR T therapy. Analysts from William Blair have supported the decision, noting that the standard lymphodepletion regimen may not lead to as robust cema-cel expansion and persistence as when ALLO-647 is included.
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Why It's Important?
The decision to halt the use of ALLO-647 is significant as it impacts the future of Allogene's lymphoma treatment strategy. The removal of ALLO-647 from the pipeline could potentially increase the safety profile of cema-cel, leading to higher commercial uptake if approved. This development highlights the challenges biotech companies face in balancing efficacy and safety in immunosuppressive therapies. The incident also underscores the importance of monitoring adverse effects in clinical trials, which can have substantial implications for patient safety and company stock performance, as evidenced by Allogene's 12% stock drop.
What's Next?
Allogene plans to conduct a futility analysis for the ALPHA3 trial in the first half of 2026. The company will continue with the FC regimen, which may offer a safer alternative for patients with lower disease burdens. The biotech industry and investors will be closely watching the outcomes of this trial to assess the viability of cema-cel without ALLO-647. The decision may also influence other companies in the sector to reevaluate their immunosuppressive strategies in light of patient safety concerns.
