Summary: The Phase 2B SurVaxM trial, testing the glioblastoma vaccine SurVaxM, will continue as planned after an interim analysis with promising results. SurVaxM, in combination with standard treatments such as surgery, radiotherapy, and chemotherapy, is designed to extend survival and improve quality of life for patients with this aggressive brain tumor.
The vaccine targets survivin, a protein that helps tumor cells avoid death. In previous studies, it has shown a strong safety profile and promising survival rates. Although the exact results remain confidential due to regulatory requirements, the decision to move forward is a promising step in the development of more effective treatments for glioblastoma.
Important facts:
- The process is ongoing: The interim analysis confirmed that SurVaxM meets the criteria for continuing the study.
- Targeted vaccines: SurVaxM targets survivin, a protein that glioblastoma cells need to survive.
- Previous results: In a previous phase 2A study, 93.7% of patients were alive one year after diagnosis.
Source: Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center announced that the Phase 2B SURVIVE clinical trial of SurVaxM for glioblastoma will move forward as planned, following a positive interim analysis of trial data.
The study is evaluating the safety, efficacy, and overall survival benefit of adding SurVaxM, a survivin‑targeting cancer vaccine to standard‑of‑care treatment, which includes surgical resection, chemoradiotherapy, and adjuvant temozolomide, in patients with newly diagnosed glioblastoma.
Following the recently completed interim non‑inferiority analysis and the ongoing evaluation by the study’s independent Data Safety Monitoring Committee, the Phase 2B SURVIVE trial (NCT05163080) will proceed as originally designed, with no modifications to its protocol. Although disclosure of detailed results of ongoing randomized controlled trials is prohibited by legal requirements, the results of the interim analysis met the established criteria for further research.
“SurVaxM is demonstrating encouraging potential as a treatment for glioblastoma when combined with standard chemotherapy and radiation,” said Ajay Abad, MD, a medical oncologist and brain tumor specialist leading the Roswell Park arm of the trial. He noted that the investigational vaccine is being evaluated for its ability to improve outcomes in patients facing one of the most aggressive forms of brain cancer.
The Roswell Park study is part of a broader research effort, with 11 SurVaxM clinical trials currently underway across the United States. These studies aim to determine whether targeting survivin — a protein that helps cancer cells evade death — can enhance the effectiveness of existing therapies and extend survival for patients. SurVaxM’s excellent safety and tolerability make it not only a valuable clinical asset but also an important contributor to preserving quality of life for patients facing this highly aggressive cancer a population in critical need of new and effective treatment options.
“Our focus remains firmly on advancing the clinic’s mission and pursuing our goal of developing innovative treatments with the potential to transform outcomes for patients with glioblastoma and other cancers,” said Michael Ciesielski, PhD, associate professor of neuroscience at Roswell Park and director of MimiVax Inc. “Every step forward brings us closer to therapies that could make a real difference for those facing these devastating diseases.”
Dr. Ciesielski added that he is energized by the steady progress of this important program, which reflects years of dedication, research, and collaboration. “I’m truly excited about the momentum we’ve built and the promise it holds for delivering new hope to patients who urgently need better treatment options,” he said.
Current Clinical Trials Involving SurVaxM
- NCT05163080 – Phase 2B survival analysis in adults with newly diagnosed glioblastoma, conducted at 11 U.S. sites. The study is fully enrolled and will proceed as planned.
- NCT04978727 (NCI PBTC‑060) – Pilot study in children with a range of brain tumors, including medulloblastoma, high‑grade glioma, ependymoma, and newly diagnosed diffuse intrinsic pontine glioma (DIPG). Led by Dr. Clare Twist, this trial is part of the Pediatric Brain Tumor Consortium, funded by the National Cancer Institute (NCI), with participation from Roswell Park and 13 other North American centers.
- NCT02334865 – Phase 1 trial in adults testing SurVaxM in combination with lenalidomide.
- NCT03879694 – Phase 1 study for adults with neuroendocrine tumors, led by Dr. Renuka Iyer at Roswell Park, currently open for recruitment.
About SurVaxM Developed
In a group of 63 patients with single anterior arm stage 2A glioblastoma treated with SurVaxM, survival outcomes were markedly better than those typically seen in similar cases without the vaccine. One year after diagnosis, 93.7% of these patients were still alive — a substantial improvement over the 65% one‑year survival rate reported in historical studies for stage 2A glioblastoma.
These findings suggest that SurVaxM, when incorporated into treatment, may offer a meaningful survival advantage for patients facing this aggressive brain cancer. While further research is needed to confirm these results in larger, randomized trials, the data add to growing evidence that targeting survivin could play a pivotal role in improving long‑term outcomes.
The research team has refined its approach to donations at Roswell Park, including fundraising events and rides to Roswell events, which are fundamental to the work of long-term researchers.
