BUFFALO, N.Y., October 7, 2026
MimiVax Inc., a clinical-stage biotechnology company developing cancer immunotherapies, in collaboration with Roswell Park Comprehensive Cancer Center, has announced results from the Phase 2b SURVIVE trial evaluating SurVaxM, an investigational cancer vaccine, in patients with newly diagnosed glioblastoma. The randomized, double-blind, placebo-controlled study evaluated SurVaxM in combination with standard of care and included 233 evaluable patients across 11 U.S. cancer centers.
SurVaxM Shows Overall Survival Benefit in SURVIVE Trial
Across the full evaluable population, SurVaxM extended median overall survival to 22.8 months, compared with 20.3 months for placebo. The treatment produced a hazard ratio of 0.75, with a 95% confidence interval of 0.54 to 1.03 and an adjusted log-rank p-value of 0.076. While the result represented a 2.5-month improvement in median overall survival, it did not reach the traditional statistical significance threshold of p=0.05 for the overall trial population. A prespecified key subpopulation produced a stronger result. Among patients 65 years of age and younger, SurVaxM demonstrated a statistically significant overall survival benefit, with median survival reaching 24.2 months versus 20.2 months for placebo. The hazard ratio was 0.64, with a 95% confidence interval of 0.44 to 0.93 and an adjusted p-value of 0.019. The same subgroup also demonstrated a significant progression-free survival benefit, with a hazard ratio of 0.64 and p=0.018. At 12 months, progression-free survival was 44% with SurVaxM compared with 24% with placebo.
Durable Survival Signal in Younger Patients
The trial analysis also highlighted a notable long-term survival signal among patients aged 65 and under. Approximately 42% of SurVaxM-treated patients remained alive through 30 months or longer, compared with 18% of patients receiving placebo. The company reported that no further deaths were observed among the SurVaxM subgroup between 30 and 54 months in the analysis. MimiVax said this level of durable survival warrants continued follow-up and further investigation in newly diagnosed glioblastoma. The company noted that the placebo arm performed better than the historical benchmark used when the study was designed, with median overall survival of 20.3 months versus an expected 16 months. According to MimiVax, the stronger contemporary standard-of-care performance increased the benchmark against which SurVaxM was evaluated and made statistically significant separation across the entire study population more difficult to achieve. SurVaxM was reported to be well tolerated in the study. The most frequently observed treatment-related effects were predominantly Grade 1 or 2 injection-site reactions, including injection-site reaction, pain, erythema, pruritus and swelling, along with influenza-like illness. Grade 3 or higher adverse-event rates were similar between treatment groups, at 48% for SurVaxM and 46% for placebo, while serious adverse events occurred in 25% and 21%, respectively. Treatment discontinuation due to adverse events occurred in 4% of SurVaxM patients, with one discontinuation attributed to study treatment, and there were no treatment-related deaths in either arm.
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MimiVax Plans FDA Discussions for SurVaxM
Following the Phase 2b findings, MimiVax plans to meet with the U.S. Food and Drug Administration to discuss the SURVIVE data and potential regulatory pathways for SurVaxM in newly diagnosed glioblastoma. The company intends to discuss potential Breakthrough Therapy Designation and other expedited pathways, including accelerated approval, although any regulatory designation or approval remains subject to FDA review. SurVaxM is a first-in-class investigational peptide-mimic immunotherapeutic vaccine designed to target survivin, a cell-survival protein found in approximately 95% of glioblastomas and several other cancers. The vaccine is intended to stimulate the patient’s immune system to recognize and attack survivin-expressing cancer cells. SurVaxM has received FDA Orphan and Fast Track Designations for newly diagnosed glioblastoma but remains investigational and has not been approved by the FDA or another regulatory authority for any indication. The SURVIVE trial has completed enrollment and is no longer accepting additional patients. MimiVax and Roswell Park plan to continue evaluating the available data as they engage with regulators regarding the next steps for SurVaxM development in glioblastoma, a disease associated with a substantial unmet medical need.
Source: MimiVax press release
