MimiVax’s experimental vaccine SurVaxM narrowly missed the primary goal in the phase 2b SURVIVE trial for newly diagnosed glioblastoma, an aggressive brain cancer.
Among 233 evaluable patients, median overall survival was 22.8 months with SurVaxM versus 20.3 months with placebo. The difference was not statistically significant (hazard ratio 0.75; P=.076), so the trial did not meet its main endpoint.
A prespecified subgroup aged 65 and under had a stronger result:
median overall survival was 24.2 months with the vaccine versus 20.2 months with placebo. The subgroup result was statistically significant, but it does not reverse the overall trial’s failure.
In that younger subgroup, 12-month progression-free survival was 44% with SurVaxM versus 24% with placebo. The findings are promising but need confirmation in further research before the vaccine can be considered proven or approved.
SurVaxM is designed to prompt an immune response against survivin, a protein found in many cancers. The study tested it alongside standard treatment; reported serious adverse-event rates were similar in the vaccine and placebo groups.
Sources:
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