RenovoRx presents interim data from TIGeR-PaC study

RenovoRx announced that Poster #CT084 is presenting detailed, open label, Phase III TIGeR-PaC study interim data analysis of its RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research, or AACR, annual meeting, on Monday, April 17 in Orlando, Florida. AACR is underway through Wednesday, April 19. The interim analysis shows a six-month median overall survival benefit for patients with locally advanced pancreatic cancer, or "LAPC, which is a 60% improvement over systemic chemotherapy, the current standard of care and study control arm. RenovoGem patients also demonstrated greater than 65% reduction in adverse events. These can include nausea, fatigue, and a decline in white blood cells. This is the first interim analysis of the randomized multi-center Phase III open label TIGeR-PaC clinical trial, designed to investigate the company’s first product candidate, RenovoGem. In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients with all patients receiving upfront induction chemotherapy and stereotactic body radiation therapy, or 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 analysis date, 45 patients from U.S. sites had been randomized in this trial. The survival status of all subjects was used for the analysis. Twenty-three patients were randomized to intra-arterial gemcitabine arm and 22 to continuation of IV gemcitabine and nab-paclitaxel arm. The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm from time of randomization. Observed a positive trend in median overall survival by 24-weeks; in this interim analysis, the statistical significance was not reached to stop the study early. Observed a 65% reduction in adverse events from control arm to treatment arm.