SELLAS's Phase 3 AML Immunotherapy Trial Expected to Fail, Per STAT Report
- SELLAS Life Sciences' galinpepimut-S (GPS) is a WT1-targeting peptide immunotherapy.
- The pivotal Phase 3 REGAL trial enrolled more than 100 acute myeloid leukemia (AML) patients in second remission, randomized to GPS versus physician's choice of treatment, with the primary goal of demonstrating improved overall survival.
- The trial is event-driven, requiring 80 patient deaths before a final analysis can be conducted; reporting indicates the event count is nearing that threshold.
- The trial's conclusion has been delayed by nearly a year.
- Per STAT News reporting by biotech columnist Adam Feuerstein, the long-delayed REGAL trial is expected to end in failure, with GPS not expected to show a survival benefit over standard of care.
- A negative outcome would represent a significant setback for SELLAS's lead clinical program.
Nearly a year late to hit its death-count threshold — that delay is the real signal in this story, not a footnote. Event-driven trials that take longer than planned to accrue events are rarely good news: if the treatment arm were meaningfully extending survival, events would accrue slower and the delay would read as encouraging, not ominous. That REGAL is reportedly headed for failure fits a pattern, not an anomaly. This is SELLAS's lead asset, so a negative confirmatory readout isn't a pipeline setback — it's closer to an existential one for a small-cap with limited runway and few near-term catalysts to fall back on. It also adds another data point to WT1-targeting peptide vaccines' long, mostly disappointing history in AML, a mechanism that has struggled to translate immunogenicity into survival benefit across multiple sponsors. Expect a sharp reassessment of remaining pipeline value, cash runway, and financing options once/if this is confirmed.
A Sellas immunotherapy study, long delayed, will end in failure ↗