Phase 2B Trial for Cancer Vaccine in Newly Diagnosed Glioblastoma Will Continue

"SurVaxM’s excellent safety profile and tolerability to date also help optimize quality of life for patients with this highly aggressive cancer, where additional treatment options are direly needed," according to Ajay Abad, MD, of Roswell Park Comprehensive Cancer Center.

Based on an interim analysis of trial data, the phase 2b SURVIVE study (NCT05163080) assessing SurVaxM, a cancer vaccine, in patients with newly diagnosed glioblastoma will continue, according to a press release from Roswell Park Comprehensive Cancer Center.1

Findings from the recently completed interim futility analysis and ongoing assessment by an independent data safety monitoring board indicated that the SURVIVE trial could continue as planned without any protocol changes.

“SurVaxM continues to show promise as a treatment option for patients with glioblastoma when paired with standard-of-care chemotherapy and radiation,” trial investigator Ajay Abad, MD, assistant professor of Oncology and Neurology in the Department of Neuro-Oncology at Roswell Park Comprehensive Cancer Center, stated in the press release.1 “SurVaxM’s excellent safety profile and tolerability to date also help optimize quality of life for patients with this highly aggressive cancer, where additional treatment options are direly needed.”

Developers designed SurVaxM as a cancer vaccine that stimulates a patient’s immune system by producing white blood cells and antibodies that recognize and attack any tumor cells that contain survivin, a molecule that helps cancer cells survive.2 Patients receive SurVaxM intravenously following surgery and radiotherapy as 4 injections over 6 weeks; the vaccine is then administered once every 3 months as maintenance.

Investigators of the prospective, multi-center SURVIVE trial are assessing the efficacy, safety, and overall survival (OS) benefit of SurVaxM in combination with standard-of-care therapy with resection, chemoradiation, and adjuvant temozolomide (Temodar) for those with newly diagnosed glioblastoma. An estimated population of 247 patients will be randomly assigned 1:1 to receive SurVaxM or placebo in combination with standard-of-care treatment.3

The trial’s primary end point is OS. Secondary end points include grade 3/4 toxicities, progression-free survival (PFS), and OS at specified time points. Other end points include objective image-based tumor response rate, molecular predictors of response to SurVaxM, and predictive value of perfusion-weighted imaging on pseudo-progression.

Patients 18 years or older with a Karnofsky performance status of 70 or higher, pathologically confirmed glioblastoma of the cerebrum, and available MGMT methylation status were eligible for enrollment on the study. Other requirements for study entry included having random assignment within 16 weeks of completing surgical resection for newly diagnosed glioblastoma, no evidence of progressive disease after chemoradiotherapy, and a dexamethasone dose of no more than 4 mg daily at the time of enrollment.

Those with recurrent or progressive glioblastoma, multicentric glioblastoma or disease involving the brainstem or cerebellum, or absence of MRI results within 72 hours of craniotomy documentation, were ineligible for study entry. Patients were also ineligible for enrollment on the study if they had a history of tuberculosis or other granulomatous disease, repeat craniotomy for tumor therapy following receipt of radiation and temozolomide, a known history of systemic autoimmune disorder, or receipt of any other investigational therapy for glioblastoma.

Investigators of a single-arm phase 2a trial (NCT02455557) previously reported that SurVaxM plus adjuvant temozolomide appeared to be safe while extending survival among patients with newly diagnosed glioblastoma.4 Across 63 evaluable patients, 60 (95.2%) achieved progression-free status at 6 months from diagnosis, and the median PFS was 11.4 months. Additionally, the median OS was 25.9 months.

“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can drive meaningful improvements for patients with glioblastoma and other cancers. We are excited about the continued advancement of this important program,” Michael Ciesielski, PhD, assistant professor of Neurosurgery at Roswell Park Comprehensive Cancer Center and chief executive officer at MimiVax Inc., the sponsor of the SURVIVE trial, concluded in the press release.1

References

1. Roswell Park announces positive progress in clinical trial of novel immunotherapy SurVaxM. News release. Roswell Park Comprehensive Cancer Center. May 8, 2025. Accessed May 12, 2025. https://tinyurl.com/37bdc89d
2. SurVaxM: immunotherapy for glioblastoma. Roswell Park Comprehensive Cancer Center. Accessed May 12, 2025. https://tinyurl.com/zvf2mjw5
3. SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma (SURVIVE) (SURVIVE). ClinicalTrials.gov. Updated February 26, 2024. Accessed May 12, 2025. https://tinyurl.com/y2r82bvh
4. Clinical trial of Roswell Park’s SurVaxM glioblastoma vaccine reveals promising results. News release. Roswell Park Comprehensive Cancer Center. December 16, 2022. Accessed May 12, 2025. https://tinyurl.com/mwbbn2ze