IDMC Backs Continuing SELLAS Phase 3 REGAL Trial After Unblinded Data Review
Updated
Updated · Seeking Alpha · Jul 14
IDMC Backs Continuing SELLAS Phase 3 REGAL Trial After Unblinded Data Review
3 articles · Updated · Seeking Alpha · Jul 14
Summary
SELLAS said the independent data monitoring committee unanimously recommended that its Phase 3 REGAL trial continue without modification after reviewing unblinded efficacy, futility and safety data.
The decision leaves the event-driven study on its current path, with the longer timeline not signaling either success or failure because completion depends on when required events occur.
FDA-approved unlimited dosing and management’s continued confidence add support for keeping the trial unchanged, but REGAL’s outcome still hinges on final data in AML patients in second complete remission.
Beyond REGAL, SELLAS also has SLS009 in development, giving the company another pipeline asset as demand remains high for better acute myeloid leukemia therapies.