SurVaxM Shows Continued Promise in Glioblastoma as Phase IIb SURVIVE Trial Progresses

Roswell Park Comprehensive Cancer Center has shared positive updates from its clinical development program evaluating SurVaxM, a vaccine targeting the protein survivin, for the treatment of patients with newly diagnosed glioblastoma. Following encouraging data from an interim analysis of the Phase IIb SURVIVE trial (NCT05163080), Roswell Park will continue moving forward with the study.¹

Encouraging interim data supports trial continuation

While detailed results are unavailable as per regulatory requirements barring the disclosure of detailed findings from randomized, controlled studies still in progress, data from the interim analysis met prespecified standards for the research to continue.

In a press release, Ajay Abad, MD, a medical oncologist and brain cancer expert leading the study at Roswell Park—one of 11 US SURVIVE trial, said: “SurVaxM continues to show promise as a treatment option for patients with glioblastoma when paired with standard-of-care chemotherapy and radiation. 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.”

Study design compares SurVaxM to placebo plus standard of care

• The randomized, placebo controlled SURVIVE trial is evaluating whether adding SurVaxM to standard temozolomide chemotherapy improves outcomes for patients with newly diagnosed glioblastoma.²
• Patients will be randomized to receive either temozolomide + SurVaxM or temozolomide + placebo.
• The primary goal is to compare overall survival between the two groups.
• The study will also assess whether SurVaxM triggers an immune response against glioblastoma cells.
• Additional objectives include monitoring the safety and potential benefits or side effects of combining SurVaxM with temozolomide.

Broader development program explores additional tumor types

Roswell Park also shared updates on three other studies involving SurVaxM:

• PBTC-060 (NCT04978727): A pilot study for pediatric patients with certain brain tumors including medulloblastoma, high-grade glioma, ependymoma, and newly diagnosed DIPG, is actively enrolling at Roswell Park and other centers through the NCI-funded Pediatric Brain Tumor Consortium.
• NCT02334865: A Phase I study in adults with multiple myeloma using SurVaxM alongside lenalidomide maintenance has finished enrollment at Roswell Park, with results expected in 2025.
• NCT03879694: This Phase I trial in adults with neuroendocrine tumors is ongoing and currently recruiting at Roswell Park.

In the press release, Michael Ciesielski, PhD, assistant professor of neurosurgery at Roswell Park and CEO of MimiVax Inc., which is sponsoring the SURVIVE trial, added: “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.”

Earlier Phase IIa study showed strong survival and durability signals

The SURVIVE trial was started based on positive outcomes from an earlier Phase IIa single-arm clinical trial (NCT02455557) of SurVaxM plus adjuvant temozolomide. Results from the study, shared by Roswell Park in December 2022, demonstrated that 60 of 63 evaluable patients were progression-free six months from diagnosis. Further, median progression-free survival was 11.4 months, and median overall survival was 25.9 months.³

In this Phase IIa study:

• A total of 63 eligible participants, aged 20 to 82, were enrolled across five sites, including Roswell Park (lead center), Cleveland Clinic, Dana-Farber, MGH Cancer Center, and Beth Israel Deaconess.
• After surgery, all patients received concurrent radiation and temozolomide.
• Within four weeks of completing chemoradiation, patients began a four-dose induction course of SurVaxM (500 mcg every two weeks).
• This was followed by ongoing SurVaxM maintenance given alongside adjuvant temozolomide, continuing until disease progression.

In a press release from the time, Ciesielski said: “We are finally starting to see immunotherapy having an impact upon difficult-to-manage diseases like glioblastoma and are excited to be able to contribute in a meaningful way to cancer care to provide hope for glioblastoma patients.”

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 July 16, 2025. https://www.roswellpark.org/newsroom/202505-roswell-park-announces-positive-progress-clinical-trial-novel-immunotherapy-survaxm

2. SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (SURVIVE). ClinicalTrials.gov. Updated February 26, 2024. Accessed July 16, 2025. https://www.clinicaltrials.gov/study/NCT05163080

3. Clinical Trial of Roswell Park’s SurVaxM Glioblastoma Vaccine Reveals Promising Results. News release. Roswell Park Comprehensive Cancer Center. December 16, 2022. Accessed July 16, 2025. https://www.roswellpark.org/newsroom/202212-clinical-trial-roswell-parks-survaxm-glioblastoma-vaccine-reveals-promising-results