SurVaxM Phase 2b SURVIVE trial reports survival benefit in patients aged 65 and under with newly diagnosed glioblastoma, with safety findings.
Written By: Mayuri Vaja, PharmD
Reviewed By: Pharmacally Editorial Team
MimiVax and Roswell Park Comprehensive Cancer Center have announced results from the Phase 2b SURVIVE trial (NCT05163080) evaluating SurVaxM, an investigational cancer vaccine, in patients with newly diagnosed glioblastoma. The randomized, double-blind, placebo-controlled study enrolled 233 evaluable patients across 11 U.S. cancer centers and evaluated SurVaxM in combination with standard-of-care treatment. Overall survival (OS) was the primary endpoint, with patients aged 65 years and under prespecified as a key subgroup.
SURVIVE Trial Shows Numerical Overall Survival Improvement
Across the full trial population, median overall survival was 22.8 months with SurVaxM compared with 20.3 months with placebo. The hazard ratio was 0.75 (95% CI, 0.54–1.03), with an adjusted log-rank p-value of 0.076.
Although the results favored SurVaxM numerically, the primary overall-survival analysis did not reach conventional statistical significance. The finding therefore does not establish a statistically significant overall-survival benefit for the full study population.
The placebo arm had a median overall survival of 20.3 months, compared with the 16-month historical benchmark used in the trial’s assumptions. The stronger-than-expected survival in the contemporary control group reduced the difference between the treatment and placebo arms and provided important context for interpretation of the primary endpoint.
Significant Survival Benefit in Patients Aged 65 and Under
A prespecified analysis showed a statistically significant overall-survival benefit among patients aged 65 years and under.
Median overall survival in this subgroup was 24.2 months with SurVaxM compared with 20.2 months with placebo. The hazard ratio was 0.64 (95% CI, 0.44–0.93; p=0.019).
Progression-free survival also favored SurVaxM in the same prespecified subgroup, with a hazard ratio of 0.64 and a p-value of 0.018. At 12 months, 44% of patients receiving SurVaxM remained progression-free compared with 24% of patients receiving placebo.
The subgroup findings are consistent with observations from an earlier Phase 2a study and support continued clinical investigation of SurVaxM in newly diagnosed glioblastoma.
Longer-Term Survival Signal Observed
The study also reported a longer-term survival signal among patients aged 65 years and under.
Approximately 42% of patients in the SurVaxM group remained alive at 30 months or longer compared with 18% of patients receiving placebo. In the reported analysis, no additional deaths were observed in the SurVaxM group between 30 and 54 months.
The companies noted that this level of long-term survival is uncommon in newly diagnosed glioblastoma and warrants continued follow-up.
These findings should be interpreted in the context of the prespecified subgroup analysis rather than as evidence of a confirmed survival benefit across the entire trial population.
SurVaxM Demonstrates a Manageable Safety Profile
SurVaxM was generally well tolerated in the SURVIVE trial. The most frequently reported adverse events were predominantly Grade 1 or 2 injection-site reactions.
Reported events included injection-site reactions in 48% of patients, pain in 41%, erythema in 39%, pruritus in 38%, and swelling in 29%. Influenza-like illness was reported in 13% of patients.
Grade 3 or higher adverse events occurred at similar rates between the SurVaxM and placebo groups, at 48% and 46%, respectively. Serious adverse events occurred in 25% and 21% of patients, respectively.
Treatment discontinuation because of adverse events occurred in 4% of patients receiving SurVaxM, with one discontinuation attributed to study treatment. No treatment-related deaths were reported in either treatment group.
SurVaxM Remains an Investigational Therapy
SurVaxM is an investigational cancer vaccine being evaluated in newly diagnosed glioblastoma. It is administered by subcutaneous injection and is designed to stimulate an immune response against tumor cells.
The SURVIVE trial has completed enrollment and is no longer open to additional patients. According to the companies, no SurVaxM studies are currently enrolling patients with glioblastoma.
SurVaxM has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication.
MimiVax Plans Further Discussions With FDA
Following the SURVIVE results, MimiVax plans to request a meeting with the U.S. Food and Drug Administration to discuss the clinical findings and potential regulatory pathways for SurVaxM in newly diagnosed glioblastoma.
The company intends to discuss Breakthrough Therapy Designation and other expedited regulatory pathways, including accelerated approval.
These represent potential regulatory pathways under discussion and do not indicate that SurVaxM has received Breakthrough Therapy Designation, accelerated approval, or marketing authorization.
What the SURVIVE Results Show
The Phase 2b SURVIVE trial produced a mixed but clinically relevant set of findings. In the full study population, SurVaxM was associated with longer median overall survival than placebo, but the difference did not reach statistical significance.
In contrast, the prespecified analysis of patients aged 65 years and under showed statistically significant improvements in both overall survival and progression-free survival, together with a longer-term survival signal.
The findings support continued evaluation of SurVaxM while highlighting the importance of interpreting the overall trial result separately from the prespecified subgroup findings. Further follow-up and regulatory discussions will determine the next steps for the investigational vaccine in newly diagnosed glioblastoma.
Reference
MimiVax and Roswell Park Announce Results from Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma, MimiVax, 07 October 2026
MimiVax and Roswell Park Announce Results from Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma, Roswell Park, 07 October 2026
SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (SURVIVE), ClinicalTrials.gov ID NCT05163080
About the Writer
Mayuri Vaja (Linkedin) is a Pharm.D professional with a strong interest in clinical research, pharmacovigilance, and medical writing, supported by certifications in pharmacovigilance and academic projects exploring AI in healthcare and drug safety.
With a growing focus on evidence-based healthcare and scientific communication, she is developing expertise in clinical research and translating healthcare evidence into clear, meaningful content.
As a Pharmacally healthcare writer, Mayuri is committed to creating accurate, research-driven, and clinically relevant healthcare content while continuously strengthening her professional skills.