A Potential New Option for Targeted Treatment of Pancreatic Cancer is on the Horizon
Systemic (IV gemcitabine and nab-paclitaxel) chemotherapy is currently the standard of care for pancreatic cancer treatment. However, it is known to cause debilitating side effects for patients diagnosed with this disease. Unlike other tumors with extensive blood supply, pancreatic tumors have poor blood supply so systemic chemotherapy may not adequately reach the tumor. Thus, the standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting systemic administration of chemotherapy to the tumor.
TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate, using the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of gemcitabine to treat LAPC following stereotactic body radiation therapy (SBRT). The study is comparing treatment of intra-arterial administration of gemcitabine versus systemic IV administration of gemcitabine and nab-paclitaxel.
The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction gemcitabine plus nab-paclitaxel and SBRT. The final analysis will be conducted after 86 protocol-specified events (i.e., patient deaths) have occurred. In addition to the final analysis, two pre-planned interim analyses are included in the statistical analysis plan.
The first interim analysis was completed in March 2023, and included 26 (30%) of the specified events. The second interim analysis will be triggered by the 52nd event (60%), which is estimated to occur in late 2024 or early 2025.
The TIGeR-PaC study is investigating TAMP therapy platform in LAPC. The study’s primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care.
TIGeR-PaC is currently enrolling unresectable LAPC patients at multiple clinical centers across the U.S.