Shown to be safe, the immunotherapy significantly extended survival
BUFFALO, N.Y. — A brain cancer vaccine developed at Roswell Park Comprehensive Cancer Center appears to be safe and significantly extends survival in newly diagnosed glioblastoma patients, according to a Phase 2A single-arm clinical trial. The study, “Phase 2A Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma,” appears in the Journal of Clinical Oncology. Manmeet Ahluwalia, MD, MBA, Fernandez Family Foundation Endowed Chair in Cancer Research, Chief of Medical Oncology, Deputy Director and Chief Scientific Officer of Miami Cancer Institute, served as overall Principal Investigator.
Building on information generated by this study, investigators have launched a Phase 2B clinical trial of SurVaxM that aims to enroll 265 newly diagnosed glioblastoma patients at 10 centers across the U.S.
The most common malignant brain tumor in adults, glioblastoma is aggressive and fast-growing. SurVaxM stimulates the immune system to attack survivin, a cancer molecule present in all glioblastomas that is vital to their survival. The vaccine was developed by Robert Fenstermaker, MD, Chair of the Department of Neurosurgery and Director of the Neuro-Oncology Program at Roswell Park, and Michael Ciesielski, PhD, of Roswell Park’s Department of Neurosurgery and CEO of MimiVax LLC, the Roswell Park spinoff company that is developing SurVaxM.
Typically, patients who are newly diagnosed with glioblastoma undergo an intensive treatment regimen that combines surgery, radiation therapy and chemotherapy, yet mortality rates remain high, with an average life expectancy of just 15 months after diagnosis.
The clinical trial was conducted to evaluate the safety of the vaccine, its effects on the immune system, and patient survival. It enrolled 63 evaluable patients, ages 20-82, at five sites, including Roswell Park (the central trial site), Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital Cancer Center and Beth Israel Deaconess Medical Center.
Following surgery, patients received radiation therapy and the chemotherapy drug temozolomide (TMZ) concurrently. Within 28 days of the chemotherapy and radiation, they received a 500-microgram dose of SurVaxM via injection every two weeks, to a total of four doses. They then received both adjuvant TMZ and a maintenance regimen of SurVaxM continually until the disease recurred.
The study reports that the combination of the vaccine and TMZ “was well tolerated, with no serious adverse events attributable to SurVaxM.” Of 63 evaluable patients, 60 (95.2%) were progression-free six months from diagnosis. Median progression-free survival was 11.4 months, and median overall survival was 25.9 months, measured from the first dose of SurVaxM.
Immune assays showed that SurVaxM generated survivin-specific CD8+ T cells, part of the immune system capable of killing cancer cells and produced anti-tumor antibody/immunoglobulin G titers that were associated with survival in trial participants.
“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,” says Dr. Ciesielski.
SurVaxM also is being evaluated at Roswell Park and several other cancer centers in the Pediatric Brain Tumor Consortium in a phase 1 clinical trial enrolling pediatric patients with various types of brain tumors, and at Roswell Park in adult patients with metastatic neuroendocrine tumors.
Survivin is present in other types of cancer as well, including multiple myeloma, and in many autoimmune diseases, including multiple sclerosis, myasthenia gravis and rheumatoid arthritis.
This study was supported by grants from the Roswell Park Alliance Foundation, Mr. Philip H. Hubbell, the Linda Scime Endowment and MimiVax LLC. The technology employed to originally develop the vaccine was funded by generous donations to the Roswell Park Alliance Foundation.
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. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.
Rebecca Vogt, Media Relations Specialist