SurVaxM Shows Survival Signal in Newly Diagnosed Glioblastoma, With Significant Benefit in Younger Patients

Clinical Summary: 

• Design/Population: The phase 2b SURVIVE trial evaluated the benefit of adding SurVaxM to standard of care in evaluable patients with newly diagnosed glioblastoma. Overall survival (OS) was the primary end point, with patients aged 65 years and younger prespecified as a key subpopulation.
• Key Outcomes: In the overall population, SurVaxM numerically improved OS and progression-free survival (PFS), but the difference did not reach statistical significance. A statistically significant OS and PFS benefit was observed in patients aged 65 years and younger, with durable long-term survival signal also observed.
• Clinical Relevance: Although the primary OS analysis in the overall population was not statistically significant, these findings support further evaluation of SurVaxM as an  immunotherapeutic approach for newly diagnosed glioblastoma, with regulatory discussions planned. 

Results from the phase 2b SURVIVE trial showed a numerical improvement in overall survival (OS) with the investigational cancer vaccine SurVaxM compared with placebo in patients with newly diagnosed glioblastoma, although the difference did not reach statistical significance. A prespecified analysis of patients aged 65 years and younger demonstrated significant improvements in OS and progression-free survival (PFS).

In this double-blind, placebo-controlled trial, 233 evaluable patients with newly diagnosed glioblastoma received standard of care with either SurVaxM or placebo. The primary end point was OS, with patients aged 65 years and younger prespecified as a key subpopulation. Secondary end points included PFS, landmark survival, safety, and survivin-specific immune responses.

Across the overall study population, median OS was 22.8 months in the SurVaxM arm and 20.3 months in the placebo arm, reducing the risk of death by 25% (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.54 to 1.03; P = .076). However, the result did not reach the conventional threshold for statistical significance. 

Among patients aged 65 years and younger, median OS was 24.2 months in the SurVaxM arm and 20.2 months in the placebo arm, reducing the risk of death by 36% (HR, 0.64; 95% CI, 0.44 to 0.93; P = .019).  

A significant PFS benefit was also observed among patients aged 65 years and younger (P = .018). The 12-month PFS rate was 44% in the SurVaxM arm and 24% in the placebo arm. 

Longer-term survival findings also favored SurVaxM in the younger subgroup. Approximately 42% of patients treated with SurVaxM aged 65 years and younger remained alive through at least 30 months compared with 18% of patients in the placebo arm. No additional deaths among these SurVaxM-treated patients were reported between 30 and 54 months.

The placebo group performed better than anticipated when the study was designed. Median OS with placebo was 20.3 months compared with the 16-month historical benchmark used in the trial assumptions, creating a higher comparator survival outcome for the primary analysis.

The most common adverse events were predominantly grade 1/2 injection-site reactions (48%), including pain (41%), erythema (39%), pruritus (38%), and swelling (29%), and influenza-like illness (13%). 

Grade ≥3 adverse events occurred in 48% of patients in the SurVaxM arm and 46% of patients in the placebo arm. Serious adverse events occurred in 25% and 21% of patients, respectively. 

Adverse events led to treatment discontinuation in 4% of patients in the SurVaxM arm, with 1 discontinuation attributed to study treatment. No treatment-related deaths occurred in either treatment arm.

SurVaxM is an investigational peptide-mimic immunotherapeutic vaccine targeting survivin, a cell-survival protein reported to be present in approximately 95% of glioblastomas. The vaccine is designed to stimulate an immune response against survivin-expressing cancer cells.

MimiVax plans to meet with the US Food and Drug Administration (FDA) to review these findings and potential regulatory pathways. SurVaxM has FDA Orphan Drug and Fast Track designations for newly diagnosed glioblastoma but is not currently approved for any indication.

Source: 

Roswell Park Comprehensive Cancer Center. MimiVax and Roswell Park announce results from phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. Accessed on: October 7, 2026. https://www.roswellpark.org/newsroom/202610-mimivax-roswell-park-announce-results-phase-2b-survive-trial-survaxm-newly