Cellectis: Promising Results Revive Hope for Allogeneic Treatment

Interim Futility Analysis Outcomes

The futility analysis, triggered on the data lock date set by the protocol for the 24th patient who completed the minimal residual disease assessment on day 45, showed that 58.3% (7 out of 12) of the patients in the cema-cel arm achieved minimal residual disease negativity, compared to 16.7% (2 out of 12) in the observation group, representing an absolute difference of 41.6%. The cema-cel treatment was generally well tolerated, with the majority of patients (10 out of 12) managed on an outpatient basis after infusion. No cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, or serious adverse events related to the treatment were recorded.

Patient Recruitment and Future Analyses

Patient recruitment for the ALPHA3 study is expected to be completed by the end of 2027. An interim analysis of event-free survival is scheduled for mid-2027, with a main analysis in mid-2028. Should the results prove positive, Allogene has indicated that it could potentially support the submission of a marketing authorization application. Under the Servier Agreement, Cellectis is eligible to receive up to $340 million in milestone payments related to development and sales, as well as double-digit royalties on net sales of licensed CD19 products.