Imvax released Phase 2b data showing a survival benefit for its glioblastoma cell‑therapy program despite missing the trial’s primary endpoint. The company reported a median overall survival improvement of roughly six months versus standard of care and signaled plans to meet with the FDA to discuss next steps. Imvax’s approach—developed by former executives at Spark Therapeutics—relies on a brain‑directed cell therapy intended to enhance immune control of glioblastoma. Management argues the overall‑survival signal justifies regulatory dialogue despite the primary outcome miss. The results illustrate a common late‑stage development dilemma: whether a secondary endpoint that demonstrates clinical benefit can support regulatory approval or conditional pathways, and how sponsors should plan confirmatory studies.
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