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News
A phase 2b trial of SurVaxM, a peptide-based vaccine for newly diagnosed glioblastoma, missed its primary overall survival endpoint in the full study population but showed a meaningful survival benefit in patients aged 65 and under. In that subgroup, median overall survival reached 24.2 months vs. 20.2 months with placebo, with 42% still alive at 30 months. The results are fueling discussions with the FDA about potential next steps.
A randomized phase 2b trial (SURVIVE) of SurVaxM — a survivin-targeting peptide vaccine — fell just short of statistical significance for its primary endpoint in 233 patients with newly diagnosed glioblastoma. Median overall survival (OS) was 22.8 months with SurVaxM vs. 20.3 months with placebo (HR 0.75; P=.076), partly because the placebo group outperformed the 16-month historical benchmark used in trial design.
The more notable findings emerged in a prespecified subgroup of patients aged 65 and younger, where SurVaxM delivered significantly longer OS (24.2 vs. 20.2 months; HR 0.64; P=.019) and progression-free survival (HR 0.64; P=.018). Notably, 42% of vaccinated younger patients were still alive at 30 months, with no additional deaths recorded through 54 months. MimiVax says the data will support upcoming regulatory discussions with the FDA.
By the Numbers
Why it matters: Glioblastoma remains one of oncology's toughest challenges, with few meaningful advances in decades. SurVaxM's signal in younger patients — described by investigators as "one of the strongest we've seen in newly diagnosed glioblastoma in a long time" — could open a new immunotherapy avenue for a population with very limited options.
