Glioblastoma Patients Receiving Combination Therapy With SurVaxM Reported Positive Immunogenicity
MiniVax immunotherapeutic cancer vaccine SurVaxM is designed to stimulate a multifaceted immune response targeting survivin
With their phase 2 study in patients with aggressive brain cancer now completed, the Roswell Park Comprehensive Cancer Center is sharing research results for the cancer immunotherapy SurVaxM.
The SurVaxM vaccine is a first-of-its-kind, patented peptide mimic immunotherapeutic vaccine (immunotherapy) that targets survivin, a cell-survival protein present in 95 percent of glioblastomas and many other cancers.
In this Phase 2 clinical trial, the research team reported that, compared to a historical analysis of patients receiving standard therapy alone, combination therapy with SurVaxM generated encouraging efficacy and immunogenicity in patients with newly diagnosed glioblastoma, with minimal toxicity or side effects.
The vast majority of patients — 96.8 percent — did not experience disease progression within 6 months of treatment.
And, 93.5 percent of patients were alive 1 year after diagnosis, compared to an expected 65 percent survival, based on historical comparisons.
All patients underwent standard treatment, involving craniotomy, radiation, and treatment with temozolomide both before and after surgery. Immune response was assessed by detection of a survivin-specific antibody and CD8+ T-cell levels.
“We essentially saw a significant increase in both progression-free and overall survival, which is noteworthy in patients with such a notoriously aggressive and treatment-resistant disease,” said Robert Fenstermaker, MD, Chair of Neurosurgery, senior author on the study.
This study included 63 patients with newly diagnosed glioblastoma (nGBM), median age 60, were followed for safety, 6-month progression-free survival, 12-month overall survival, and immunologic response.
Glioblastoma is the most common form of brain cancer in adults, and also the most aggressive. Current treatment options at diagnosis are multimodal and include surgical resection, radiation, and chemotherapy. The median survival for patients treated with standard therapy is 14.7 months.
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SurVaxM was awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2017. New studies incorporating SurVaxM are expected to open at both Cleveland Clinic and Roswell Park in the coming months.
Drs. Fenstermaker and Ciesielski gratefully acknowledge donations to Roswell Park in support of their work.
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Learn more at Roswell Park.
MimiVax has an exclusive license to globally commercialize SurVaxM, as well as an extensive worldwide patent portfolio for SurVaxM and other products in development.
- SurVaxM with standard therapy in newly diagnosed glioblastoma: Phase II trial update.
- Phase II Trial Shows Favorable Response for Patients Receiving Combination Therapy With SurVaxM
- FDA Awards Orphan Status to Brain Cancer Vaccine Developed at Roswell Park Comprehensive Cancer Center
- SurVaxM Phase I Completed
- What is the Role of Tumor-treating Fields in Newly Diagnosed Glioblastoma?