MimiVax and Roswell Park Announce Results from Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma

Statistical significance in overall survival benefit was achieved in patients aged 65 and under.

By
October 7, 2026
7 min

Roswell Park Comprehensive Cancer Center

Overview

In the randomized, double-blind Phase 2b SURVIVE trial, SurVaxM was associated with median overall survival of 22.8 months versus 20.3 months with placebo across 233 evaluable patients; the difference did not reach statistical significance (HR 0.75; p=0.076). In the prespecified subgroup aged 65 years or younger, overall and progression-free survival favored SurVaxM, with statistically significant differences reported. The company reported that SurVaxM was generally well tolerated and plans to discuss the results and a potential expedited regulatory pathway with the FDA.

Background

Glioblastoma is a serious brain cancer for which the source describes limited progress over the past two decades. The SURVIVE trial evaluated SurVaxM, a cancer vaccine, in newly diagnosed patients and included a placebo comparison to account for changes in standard care over time. Earlier Phase 2a results had provided a survival signal, while the randomized Phase 2b study was designed to assess outcomes against placebo. The supplied context describes vaccine immunotherapy in glioblastoma as investigational.

Data Highlights

Outcome	SurVaxM	Placebo	Reported comparison
Median overall survival, all evaluable patients (n=233)	22.8 months	20.3 months	HR 0.75; 95% CI 0.54–1.03; p=0.076
Median overall survival, patients aged 65 years or younger	24.2 months	20.2 months	HR 0.64; 95% CI 0.44–0.93; p=0.019
Progression-free survival, patients aged 65 years or younger	Favored SurVaxM		HR 0.64; p=0.018
Progression-free survival at 12 months, patients aged 65 years or younger	44%	24%	Reported subgroup result
Alive through 30 months or longer, patients aged 65 years or younger	42%	18%	Reported as approximately double with SurVaxM
Grade 3 or higher adverse events	48%	46%	Rates were similar
Serious adverse events	25%	21%	Overall rates

Key Findings

The primary endpoint, overall survival in all 233 evaluable patients, was not statistically significant: median 22.8 months with SurVaxM versus 20.3 months with placebo (HR 0.75; 95% CI 0.54–1.03; p=0.076).
In the prespecified subgroup aged 65 years or younger, median overall survival was 24.2 months with SurVaxM and 20.2 months with placebo (HR 0.64; 95% CI 0.44–0.93; p=0.019).
In that age subgroup, progression-free survival favored SurVaxM (HR 0.64; p=0.018), and 12-month progression-free survival was 44% versus 24%.
The company reported that approximately 42% of SurVaxM-treated patients aged 65 years or younger were alive through 30 months or longer, compared with 18% in the placebo group; no further deaths in the SurVaxM subgroup were reported from 30 through 54 months.
The placebo group’s median overall survival was 20.3 months, above the trial’s 16-month historical benchmark cited in the announcement.
Reported adverse events were predominantly Grade 1 or 2 injection-site reactions and influenza-like illness. Grade 3 or higher adverse-event rates were 48% with SurVaxM and 46% with placebo; there were no treatment-related deaths in either arm.

Clinical Implications

The overall-population primary endpoint was not statistically significant, while the prespecified subgroup aged 65 years or younger showed statistically significant overall- and progression-free-survival results. The announcement describes these as initial results and states that continued follow-up and investigation are warranted; MimiVax intends to discuss the data and a potential expedited regulatory pathway with the FDA.

Conclusion

SURVIVE reported a survival signal for SurVaxM, including statistically significant results in patients aged 65 years or younger, but did not demonstrate a statistically significant overall-survival difference in the full evaluable population. Further follow-up and regulatory discussion are planned, according to the announcement.