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NewsA phase 2b trial of SurVaxM, a first-in-class cancer vaccine targeting survivin, narrowly missed its primary overall survival endpoint in newly diagnosed glioblastoma — but delivered a statistically significant survival benefit in patients aged 65 and under. With a median OS of 24.2 vs. 20.2 months in that subgroup, researchers are calling it one of the strongest signals seen in this disease in years. The developer plans to seek FDA discussions on a path forward.
A novel cancer vaccine for one of medicine's toughest diagnoses came tantalizingly close to a breakthrough. The phase 2b SURVIVE trial of SurVaxM — a peptide-mimic vaccine targeting survivin, a protein found in nearly all glioblastomas — missed its primary overall survival (OS) endpoint in the full study population of 233 newly diagnosed glioblastoma patients. However, the data tell a more nuanced story, especially for younger patients.
In a prespecified subgroup of patients aged 65 or younger, SurVaxM delivered statistically significant improvements in both OS and progression-free survival (PFS). Notably, 42% of vaccinated patients in this group were still alive at 30 months, with no additional deaths recorded between 30 and 54 months — a striking plateau in a disease where progress is typically measured in weeks. The safety profile was reassuring, with grade 3+ adverse events occurring at similar rates in both arms and no treatment-related deaths.
By the Numbers:
Why it matters: Glioblastoma has seen few meaningful treatment advances in decades. While SurVaxM didn't cross the statistical finish line in the full population, its signal in younger patients — combined with its favorable safety profile — has MimiVax pursuing FDA discussions on breakthrough therapy designation and accelerated approval pathways.