Sellas's Delayed AML Trial Looks Poised to Miss Survival Goal, Analysis Suggests
- GPS (galinpepimut-S), Sellas Life Sciences' cancer immunotherapy, is being tested in the Phase 3 REGAL trial in acute myeloid leukemia (AML) patients who are in a second remission after at least two prior lines of therapy.
- REGAL enrolled more than 100 patients; its primary endpoint is overall survival versus standard of care.
- The trial has an event-driven design requiring 80 patient deaths to trigger the final survival analysis; as of the latest count, 72 of the 80 required events had occurred.
- Completion has slipped nearly a year past original timelines — a pace a Sept. 17, 2026 STAT News analysis reads as concerning, since slower-than-expected death accrual can hint that a drug isn't extending survival as hoped.
- This failure prediction is informed analyst/columnist speculation based on trial mechanics and the delay pattern, not an official, sponsor-confirmed readout.
Trial-watchers read event-driven Phase 3s by the clock, not the topline: REGAL needs 80 deaths to unlock its survival readout, and sitting at 72/80 nearly a year behind schedule is the kind of pattern sophisticated observers flag as a soft signal, not a verdict. Slower death accrual can mean GPS is genuinely extending survival — the optimistic read — but it's equally consistent with sluggish enrollment, extended follow-up, or censoring quirks unrelated to efficacy; event-driven mechanics are inherently ambiguous until the data actually locks. What is real: this is a binary, pipeline-defining catalyst for a small-cap with limited depth beyond GPS in AML. A negative readout would sharply narrow strategic options — partnership leverage, cash runway, follow-on financing — while a positive one could be a rare re-rating story. Until REGAL formally reads out, this remains informed speculation, not a confirmed result.
A Sellas immunotherapy study, long delayed, will end in failure ↗