Novel Cancer Vaccine Plus Temozolomide Miss Primary End Point in Glioblastoma

The survivin-targeted vaccine SurVaxM did not meet statistical significance for its primary end point of overall survival (OS) in the full population of the phase 2b SURVIVE trial (NCT05163080), according to a press release from the developer, MimiVax, and Roswell Park Comprehensive Cancer Center.^1,2 In contrast, it did show a statistically significant OS benefit in a prespecified subgroup of patients 65 years and younger with newly diagnosed glioblastoma (GBM).

What were the efficacy results from the SURVIVE trial?

In the overall population (n = 233), the median OS was 22.8 months with SurVaxM vs 20.3 months with placebo (HR, 0.75; 95% CI, 0.54-1.03; P = .076). The difference did not cross the conventional threshold for statistical significance, which was P = .05. In the prespecified subgroup of patients 65 years and younger, the median OS was 24.2 months with SurVaxM vs 20.2 months with placebo (HR, 0.64; 95% CI, 0.44-0.93; P = .019).

Progression-free survival (PFS) was also improved in this subgroup (HR, 0.64; P = .018), with 12-month PFS rates of 44% vs 24% with SurVaxM vs placebo, respectively. Among patients 65 years and younger, 42% of those who received SurVaxM were alive at 30 months or longer vs 18% of those who received placebo. No additional deaths were reported in the SurVaxM arm through 54 months.

“For patients 65 and under, this is one of the strongest signals we have seen in newly diagnosed glioblastoma in a long time,” Robert Fenstermaker, MD, co-principal investigator of the trial, chair emeritus of neurosurgery at Roswell Park, and chief medical officer and cofounder of MimiVax, stated in the news release.¹

The investigators noted that the placebo arm in the SURVIVE trial exceeded the assumptions made during design of the trial, which expected a 16-month historical benchmark.

How was the SURVIVE trial designed?

SURVIVE is a randomized, double-blind, placebo-controlled, multicenter phase 2b trial evaluating SurVaxM in combination with standard care in patients with newly diagnosed GBM. The trial enrolled 233 evaluable patients across 11 US cancer centers. The primary end point was OS, and patients 65 years and younger were prespecified as a key subpopulation. Secondary end points included the rate of grade 3/4 toxicities and PFS.

What was the safety profile of SurVaxM?

The most common adverse events (AEs) were grade 1 or 2 injection-site reactions (48%), including pain (41%), erythema (39%), pruritus (38%), and swelling (29%), as well as influenza-like illness (13%). Grade 3 or higher AEs occurred in 48% of patients in the SurVaxM arm and 46% in the placebo arm. Serious AEs were reported in 25% vs 21% of patients, respectively. Treatment discontinuation due to AEs occurred in 4% of patients receiving SurVaxM, with 1 discontinuation attributed to study treatment. No treatment-related deaths were reported.

“Every patient with glioblastoma is facing one of the hardest diagnoses in medicine,” Ajay Abad, MD, principal investigator of the trial and assistant professor at Roswell Park, stated in the news release.¹ “To see many of our study patients living longer, and several of them living years longer, is deeply meaningful to every one of us who has participated in the work to develop and study this new treatment approach.”¹

What is SurVaxM?

SurVaxM is a first-in-class peptide-mimic immunotherapeutic vaccine that targets survivin, a protein present in approximately 95% of GBMs and in many other cancers. It is administered subcutaneously and designed to stimulate immune recognition of survivin-expressing tumor cells. The agent has received orphan drug and fast track designations from the FDA for newly diagnosed GBM and remains investigational. In addition to glioblastoma, SurVaxM is being evaluated in neuroendocrine tumors, multiple myeloma, and pediatric brain cancers.

The developers stated that they plan to request a meeting with the FDA to discuss the data and potential expedited pathways, including breakthrough therapy designation and accelerated approval.

References

1. MimiVax and Roswell Park announce results from phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. News release. MimiVax Inc. October 7, 2026. Accessed October 7, 2026. https://tinyurl.com/yek2ru2h
2. MimiVax and Roswell Park announce results of phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. News release. Roswell Park Comprehensive Cancer Center. October 7, 2026. Accessed October 7, 2026. https://tinyurl.com/zepnanuh