MimiVax is pleased to announce the published manuscript of the now completed Phase IIa study of SurVaxM, a cancer vaccine, in newly diagnosed glioblastoma (nGBM) in the Journal of Clinical Oncology, authored by researchers from several prominent US cancer centers. Glioblastoma is a rare disease with severe unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years. The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care.
MimiVax announces positive Phase 2A SurVaxM data in GBM, 2yr survival rate of 51%, published in JCO
This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557]. All participants signed an informed consent prior to participation and study related tests. Patients were enrolled and treated at the following institutions: Roswell Park Comprehensive Cancer Center (which also served as the central trial site), Beth Israel Deaconess Medical Center, Cleveland Clinic, Dana-Farber Cancer Institute and Massachusetts General Hospital.
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Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint. Additional endpoints of median Progression Free Survival (mPFS) of 11.4 months and median Overall Survival (mOS) of 25.9 months, measured from first dose of SurVaxM. SurVaxM was shown to stimulate survivin-specific cytotoxic T-cells and produce anti-tumor antibody responses which correlated with survival. Patients with the strongest antibody responses had a mOS of 43.1 mos. SurVaxM appeared to be safe and well-tolerated and may represent a promising new therapy emerging for nGBM.
“These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma. Additionally, we are excited about the benefit that was seen in both in the methylated [temozolomide-sensitive] and unmethylated [temozolomide-resistant] patients. There has also been significant interest in the randomized Phase IIb ongoing study.” -Manmeet Ahluwalia, MD, MBA; Fernandez Family Foundation Endowed Chair in Cancer Research, Chief of Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida.
SOURCE: PR Newswire