OncXerna Therapeutics Announces Upcoming ASCO Poster Featuring Data Showing the Phase 2 Glioblastoma Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide Met its Primary Endpoint
Trial’s 73% twelve-month overall survival rate in newly diagnosed glioblastoma patients compares favorably to historical benchmark of 60%
Results show median progression-free survival of 6.9 months and median overall survival of 15.4 months
Treatment led to depletion of immunosuppressive myeloid-derived suppressor cells within the tumor microenvironment, suggesting bavituximab may synergistically combine with checkpoint inhibitors
Excerpt from the Press Release:
WALTHAM, Mass., June 03, 2022 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced new clinical data from an investigator-sponsored Phase 2 trial evaluating bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients. The data, which show that the trial met its primary endpoint, will be featured in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place both virtually and in-person at the McCormick Place Convention Center in Chicago, Illinois.
Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor designed to reverse immune suppression. The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP)-funded Phase 2 investigator-sponsored trial that will be featured in the ASCO poster was an open-label, single-arm study in newly diagnosed IDH wild-type GBM patients that was designed to evaluate the safety and efficacy of bavituximab combined with chemoradiation and adjuvant temozolomide. Per the trial protocol, success on the primary endpoint was defined as a twelve-month overall survival rate (OS-12) of greater than or equal to 72% in evaluable patients.
“Novel approaches are needed to treat GBM, as the current standard-of-care of chemoradiation and temozolomide has historically provided an OS-12 of only 60%,” said Elizabeth Gerstner, M.D., Mass General Cancer Center, the study’s lead investigator. “The Phase 2 results being presented at ASCO suggest bavituximab modulates the immunosuppressive GBM microenvironment, demonstrating its on-target effects. The OS-12 of evaluable patients exceeded both the study’s pre-specified criteria and the historical benchmark. Improved survival also correlated with positive changes in tumor immune cell gene expression and reductions in cerebral blood flow, which indicates that bavituximab was a contributor to treatment response and supports continued clinical evaluation in GBM.”
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