Sellas GPS Study Delayed Nearly a Year, Predicted to Fail — SkimNews
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- Sellas Life Sciences is running the Phase 3 REGAL study of its experimental immunotherapy galinpepimut-S (GPS) in acute myeloid leukemia patients in second remission, testing it against standard treatment
- Galinpepimut-S faces a predicted negative outcome from the REGAL study, with author Adam Feuerstein saying he's confident GPS will fail to prolong survival compared to standard care
- The REGAL trial is event-driven and has been delayed by nearly a year from its expected conclusion, which the source says raises significant doubts about GPS efficacy
- Sellas is characterized in the piece as 'a blowup waiting to happen,' with Feuerstein noting he doesn't know when the negative outcome will be confirmed but is certain it will come
Why it matters: The nearly year-long delay in an event-driven study is itself the signal — the treatment isn't generating the survival events needed to trigger readout, implying GPS isn't performing as hoped. For acute myeloid leukemia patients in second remission, a group with limited treatment options, this likely closes the door on a long-awaited immunotherapy candidate. Sellas, built around GPS as its core asset, now faces confirmation of what the delay already implied.
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