Roswell Park Comprehensive Cancer Center has become the first center to treat patients in a newly opened phase 2B clinical trial investigating SurVaxM, a peptide mimic immunotherapy for patients with newly diagnosed glioblastoma. The multicenter randomized SURVIVE trial (NCT05163080) aims to build on promising early results that showed significantly improved survival rates compared to standard treatment.
SurVaxM Shows Promising Results in Earlier Studies
In a previous phase II study (NCT024455557) involving 63 patients with newly diagnosed glioblastoma, SurVaxM demonstrated remarkable efficacy. Results showed that 96.8% of patients remained progression-free within 6 months of treatment, and the 12-month overall survival rate reached 93.5%, significantly higher than the 65% observed with historical controls. The median overall survival was 14.7 months.
The vaccine also showed encouraging immunogenicity with limited toxicities, making it a promising candidate for further investigation in this difficult-to-treat cancer.
"For years, we've struggled to move the needle as far as good treatment options for glioblastoma," said Dr. Ajay Abad, principal investigator and neurologic oncologist at Roswell Park Comprehensive Cancer Center. "Our hope is that SurVaxM will offer patients both longer survival and better quality of life. To hopefully be on the precipice of meaningful progress against glioblastoma and to be able to possibly see my patients outside of the hospital—years after their diagnosis—would be incredible."
SURVIVE Trial Design and Objectives
The SURVIVE trial will evaluate 265 patients with newly diagnosed glioblastoma across approximately 15 sites in the United States and China. Participants will be randomized to receive either SurVaxM with sargramostim plus adjuvant oral temozolomide in the experimental arm, or saline-montanide emulsion plus adjuvant oral temozolomide in the comparator arm.
The primary endpoint of the study is overall survival, with secondary endpoints including:
- Number of grade 3/4 toxicities
- Progression-free survival
- Overall survival at specified time points
- Progression-free survival at specified time points
Exploratory endpoints include the predictive value of perfusion-weighted imaging, objective image-based tumor response rate, and evaluation of molecular predictors of response to SurVaxM.
Patient Eligibility Criteria
To be included in the study, patients must:
- Be 18 years of age or older
- Have a Karnofsky performance status ≥ 70
- Have pathologically confirmed diagnosis of glioblastoma of the cerebrum
- Demonstrate adequate laboratory values
- Have available results from tumor MGMT methylation and tumor IDH1 mutation tests
- Have completed initial radiation therapy and be 16 weeks post-surgery
- Show no evidence of progressive disease post-chemoradiation
- If on dexamethasone at enrollment, be receiving less than 4 mg daily
Patients who previously received immunotherapy, tumor treating fields, or bevacizumab (Avastin) are ineligible to enroll, as are those with certain infections or disorders that may interfere with the investigational treatment.
The Science Behind SurVaxM
SurVaxM was developed at Roswell Park by Dr. Robert Fenstermaker, Chair of Neurosurgery, and Dr. Michael Ciesielski, Assistant Professor of Oncology. The immunotherapy targets survivin, a protein that helps cancer cells stay alive. This novel approach represents a potential breakthrough in glioblastoma treatment, which has seen limited advances in recent decades.
"Glioblastoma is a notoriously aggressive and hard-to-treat cancer. We are encouraged by the results from our earlier studies and excited to bring this treatment option to more brain cancer patients at more centers," said Dr. Fenstermaker.
The Urgent Need for New Glioblastoma Treatments
Glioblastoma, though rare, is the most common primary brain cancer. It is characterized by its fast-growing and aggressive nature. Standard treatment typically includes surgery, chemotherapy, and radiation, but the cancer frequently recurs within a year of initial treatment. The median survival for patients with standard therapy is approximately 16 months.
The development of SurVaxM represents a potential paradigm shift in glioblastoma treatment, moving beyond conventional approaches to harness the power of the immune system against this devastating disease.
Currently, patients are being recruited at Roswell Park Comprehensive Cancer Center in Buffalo, New York, Atlantic Health in Summit, New Jersey, and the Dana-Farber Cancer Institute in Boston, Massachusetts, with additional sites expected to open as the trial progresses.
The research team acknowledges that donations to Roswell Park, both direct and through events like the Ride for Roswell, have provided critical support for their work through all phases of development.
