- SELLAS Life Sciences ( NASDAQ: SLS ) shed ~39% on Monday after delaying the interim analysis of its Phase 3 registrational clinical trial for lead asset galinpepimut-S (GPS) to late 2023 or early 2024 from the previous timeline of early 2023.
- The postponement comes after the company implemented certain changes to the protocol and statistical analysis of the REGAL trial, which was designed to evaluate GPS in certain acute myeloid leukemia (AML) patients who have achieved complete remission.
- The company made the changes after a review of early data indicated about two-fold longer than anticipated median overall survival (OS) in the pooled study population. As a result, the overall length of the trial could be longer than previous expectations, SELLAS ( SLS ) said.
- Chief Executive Angelos Stergiou noted that the efficacy of GPS or better care received by patients in the control arm could be among the reasons for longer OS. “However, without unblinding the study, it is currently impossible to confirm or refute any of the possibilities,” he added.
- The update on the REGAL trial coincided with the company’s Q3 2022 results.
For further details see:
SELLAS falls 39% on delay for key milestone for cancer drug