SELLAS announces positive interim analysis for Phase 3 REGAL trial of GPS in AML; IDMC recommends continuation

SELLAS Life Sciences Group, Inc.

IDMC recommended continuation of Phase 3 REGAL trial after interim analysis triggered by 60 deaths; no safety concerns.
Blinded data: fewer than 50% of patients deceased after median follow-up of 13.5 months; pooled median survival >13.5 months vs ~6 months historical.
Blinded immune response: 80% of GPS patients showed GPS-specific T-cell response, exceeding prior Phase 2 result of 64%.
Next final analysis planned at 80 events, expected in 2025; company preparing BLA submission.

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