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RenovoRx Announces New Positive Interim Phase III Data Demonstrating RenovoGem™ Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer
Six-Month Overall Survival Benefit with RenovoGem Versus Systemic Chemotherapy, and 65% reduction in adverse effects and clinically meaningful overall
About this update from Renovorx, Inc.
[{"type":"text","content":"\nSix-Month Overall Survival Benefit with RenovoGem Versus Systemic Chemotherapy, and 65% reduction in adverse effects and clinically meaningful overall survival trend\n\n\nResults highlight RenovoGem’s potential to change treatment paradigm for Locally Advanced Pancreatic Cancer\n\n\n LOS ALTOS, Calif.--(BUSINESS WIRE)--\nRenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today presented new positive data on progression-free survival (PFS) from the pivotal Phase III open label TIGeR-PaC study of RenovoGem (intra-arterial administration of gemcitabine) in locally advanced pancreatic cancer (LAPC). The interim data was featured as a late-breaking oral presentation at the 2023 ESMO World Congress on Gastrointestinal Cancer, and presented by Michael J. Pishvaian, M.D., Ph.D., Johns Hopkins Medicine and Principal Investigator (PI) of the TIGeR-PaC study.\n\n\nThe interim analysis demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care. PFS is the measure of the length of time from study randomization to either death or progression of disease.\n\n\n“Clinical practice has been waiting decades for a meaningful advancement in the standard of care for pancreatic cancer treatment, with less toxicity and better outcomes. The new data from the TIGeR-PaC interim results support that RenovoGem has the potential to more than double progression-free survival compared to systemic chemotherapy alone in this difficult-to-treat cancer, which demonstrates support for a new treatment standard,” said Michael J. Pishvaian, M.D., Ph.D., PI of the TIGeR-PaC study. “This data has the potential to be a paradigm-shifting treatment for patients at risk of cancer progression, including those who have limited well-tolerated options.”\n\n\nThe study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and stereotactic body radiation therapy (SBRT). The TIGeR-PaC Data Monitoring Committee met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the date of the analysis, 45 patients from U.S. sites had been randomized in this trial and the sur...