Imvax reported Phase 2b data in glioblastoma showing no hit on the trial’s primary endpoint but a clinically meaningful overall survival benefit — roughly six months longer than standard of care — prompting the company to prepare a meeting with the FDA. The program is a cell‑based immunotherapy developed by a team of experienced executives formerly of Spark Therapeutics. Imvax argues that the survival signal outweighs the missed primary endpoint and plans regulatory engagement to discuss potential approval pathways. Company filings and presentations emphasize the survival data, safety profile and next‑step development plans while acknowledging additional confirmatory trials may be required. The case underscores the regulatory and evidentiary tradeoffs in oncology where secondary outcomes like overall survival can drive discussions even when primary endpoints fall short.