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Biothera Pharmaceuticals Presents Clinical Data from Phase 2 Study Evaluating the Combination of Imprime PGG and Merck's KEYTRUDA in Triple Negative Breast Cancer at 2019 ASCO Annual Meeting
EAGAN, Minn., June 01, 2019 (GLOBE NEWSWIRE) -- Biothera Pharmaceuticals, Inc. announced today primary data from IMPRIME 1, a Phase 2 clinical trial evaluating Imprime PGG, Biothera’s dectin receptor agonist, and KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc. (known as MSD outside the United States and Canada), in chemo-refractory metastatic triple negative breast cancer (mTNBC) patients. The findings will be highlighted in a poster presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, June 1 from 8:00 AM-11:00 AM Central Time. “These early data suggest that Imprime PGG, which activates both the innate and adaptive immune response, in combination with anti-PD-1 immune checkpoint inhibitor therapy is a promising approach to cancer treatment, specifically triple negative breast cancer,” said Steven J. O’Day, M.D., the study’s principal investigator and Executive Director of the John Wayne Cancer Institute and Cancer Clinic at Providence Saint John's Health Center, Director of Providence Los Angeles Regional Research, and a Professor of Medical Oncology. “These data clearly support additional research for this therapeutic combination.” “These data represent compelling evidence that Imprime PGG, when added to immune checkpoint inhibitors, may provide substantial benefit for patients with triple negative breast cancer,” said Jeremy Graff, Ph.D., President and Chief Scientific Officer, Biothera Pharmaceuticals. “Importantly, this study, which is heavy on translational research, shows not only clinical proof of concept but also mechanistic proof of concept for Imprime PGG. Accordingly, these data give us confidence in taking the next step to advance Imprime PGG further into clinical development.” Key Findings from IMPRIME 1 in mTNBC In addition, confirmed responses were evident in patient subpopulations with poor prognosis: Patients with high lactate dehydrogenase (LDH) levels, visceral metastases and liver metastases. The benefit for patients with liver metastases is unprecedented for KEYTRUDA alone. IMPRIME 1 Response and Survival Data. Previous checkpoint inhibitor monotherapy studies in mTNBC are shown for context.
No concerning safety signals were observed in the study. Overall, the treatment combination was well tolerated and the incidence of adverse events (AEs) was similar to safety observations in previous Imprime PGG studies involving more than 400 cancer patients and reflective of the disease and the known safety profile of KEYTRUDA. Common AEs associated with the use of Imprime PGG include hypersensitivity/infusion-related reactions, generally of mild to moderate severity and frequently mitigated with administration of premedication. Study Design and Additional Data From IMPRIME 1 The primary endpoint was ORR by RECIST v1.1 and safety, and secondary endpoints included OS and DCR. Pre- and on-therapy tumor biopsies were collected to assess immune activation at the tumor site. The tissue samples showed that Imprime PGG induced heavy infiltration of activated immune cells (M1 state, PD-L1+) and activated CD8 and CD4 T cells. On-treatment peripheral blood samples showed Imprime PGG-specific innate immune cell mobilization and activation, as well as enhanced T cell activation. “Immune activation was evident in both tumor biopsy tissues and in peripheral blood. These immuno-pharmacodynamic changes were evident as early as three weeks on treatment in peripheral blood and mark the patients who experienced the greatest clinical benefit,” said Dr. Graff. About Biothera Pharmaceuticals, Inc. Contact: |