Interim Results from Clinical Trial of Immunotherapy for Glioblastoma Show Significant Clinical Benefit
Team from Roswell Park, MimiVax LLC and Cleveland Clinic to report findings on SurVaxM at ASCO Annual Meeting
- Combination of SurVaxM and standard therapy being studied in phase II trial
- Interim analysis shows combo was well-tolerated, with few serious side effects
- Significant overall-survival benefit compared to historical standard of care
Newswise — BUFFALO, N.Y. — The research team behind an emerging immunotherapy for cancer will present interim findings from an ongoing clinical study in patients with brain cancer at a major research meeting next month. Collaborators from organizations including Roswell Park Comprehensive Cancer Center, the Cleveland Clinic and MimiVax LLC will share data from their phase II study of SurVaxM as part of a combination treatment for patients with glioblastoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. These results show that the therapy appears to be safe, effective and worthy of further evaluation.
Glioblastoma is the most common and aggressive form of primary brain cancer in adults. With standard therapy — surgery followed by chemoradiation and then adjuvant chemotherapy — the median overall survival is 15 months, with only 3-5% of patients living 5 years or more.
The researchers are exploring whether adding SurVaxM to standard therapy improves outcomes for patients with newly diagnosed glioblastoma. Analyzing results to date for 63 patients treated with this combination, the team found that 91% of patients receiving SurVaxM as part of this combination therapy were still living 12 months after initiating treatment, compared to 61% in a historical analysis of patients treated with standard therapy alone, and that 96% achieved six-month progression-free survival, compared to 54% among the historical comparison group. Moreover, 13 of 63 patients continue to be without progression a year or longer into their participation in the study.
“These interim phase II trial results in newly diagnosed glioblastoma patients are very promising and offer the potential for longer-term survival in this group where there is great unmet medical need,” says the study’s senior author, SurVaxM co-inventor Robert Fenstermaker, MD, who is Chair of Neurosurgery at Roswell Park and Chief Medical Officer at MimiVax. “We believe this drug has the potential to change the glioblastoma treatment paradigm.”
SurVaxM, which was invented at Roswell Park, targets a cell-survival protein called survivin that is present in 95% of patients with glioblastomas, and also in patients with many other cancers. Awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2017, the vaccine has dual mechanisms of action to stimulate a patient’s T- cell immunity and also employs antibody-directed inhibition of the survivin pathway to control tumor growth and prevent or delay tumor recurrence.
“Glioblastoma is one of the most common and aggressive forms of brain cancer, with few effective treatment options. That dire need underscores the importance of these promising interim results, as we seek to develop new and better therapies,” notes co-inventor Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and Chief Executive Officer for MimiVax. “And because survivin is present in a huge percentage of cancers in general, we expect that SurVaxM could have broad applicability in many cancers beyond glioblastoma.”
The team will present these initial findings during the “Central Nervous System Tumors” session on Saturday, June 2, 2018 from 1:15–4:45 p.m. CDT in Hall A of the McCormick Place conference center. Manmeet Ahluwalia, MD, of the Cleveland Clinic is overall principal investigator of the phase II trial and first author of the study, “Phase II trial of SurVaxM combined with standard therapy in patients with newly diagnosed glioblastoma” (abstract 2041).
The single-arm study is being conducted at five sites: Roswell Park Comprehensive Cancer Center, the Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. The team’s work has been supported by donations to Roswell Park and through private investment.
A randomized trial of SurVaxM in glioblastoma is planned, pending completion of this study. Research on SurVaxM has led to the development of additional platform agents, including a therapeutic anti-survivin monoclonal antibody and survivin-targeted CAR T cells, both of which are under development by scientists and clinicians at MimiVax and Roswell Park.
For more information about the phase II clinical trial, call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to AskRoswell@Roswellpark.org. Additional details are available here.
This release is also available on the Roswell Park website: https://www.roswellpark.org/media/news/interim-results-clinical- trial-immunotherapy-glioblastoma-show-significant-clinical
About MimiVax LLC:
MimiVax LLC is a New York based private, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutics for cancer treatment. The Company was formed in 2012 to develop and commercialize its lead candidate SurVaxM. SurVaxM is currently undergoing Phase II study in glioblastoma and Phase I study in multiple myeloma. For more information on MimiVax, visit www.mimivax.com.
About Roswell Park:
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.