Data from the phase 3 TIGeR-PaC trial indicates that patients with locally advanced pancreatic cancer experienced notable survival benefit with RenovoGem vs chemotherapy.
Treatment with RenovoGem resulted in an overall survival (OS) benefit and decreased adverse effects (AEs) compared with chemotherapy, according to a press release on results from an interim analysis of the phase 3 TIGeR-PaC trial (NCT03257033).1
Investigators identified a 6-month median OS benefit following treatment with RenovoGem equaling approximately 60% compared with gemcitabine and nab-paclitaxel in locally advanced pancreatic cancer. The median OS was 16 months vs 10 months in each arm, respectively. Investigators also reported a trend in median OS at 24-weeks, although statistical significance that would warrant stopping the study early was not reached (P = .051).
Moreover, patients in the experimental arm experienced a 65% reduction in AEs vs the control group, which included toxicities such as nausea, fatigue, and white blood cell decrease. Investigators reported 4 serious AEs in the experimental arm compared with 11 in the control arm.
The next interim analysis is expected to read out mid-2024.
“Results from the interim analysis echo the phase 1/2 data and observational studies. The TIGeR-PaC clinical trial is ongoing, but it appears RenovoGem enhances patient survival and has fewer [AEs] than the standard of care treatment that impacts the entire body of a patient rather than the targeted treatment area,” principal investigator, Michael J. Pishvaian, MD, PhD, director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, and an associate professor of Oncology at Johns Hopkins Medicine, said in the press release. “This is important because treatment of [locally advanced prostate cancer] is often limited to systemic, high dose, [intravenous] chemotherapy. It often has debilitating [AEs].”
The open label phase 3 study uses the RenovoTAMP—RenovoRx Trans-Arterial Micro-Perfusion—platform to deliver intra-arterial gemcitabine following stereotactic body radiotherapy.2 The primary end point of the trial was OS, with key secondary end points including progression-free survival, objective response rate, health-related quality of life, patient-reported symptoms, and safety.
Investigators of the trial randomly assigned 114 patients 1:1, totaling 57 patients in each arm. At the time of the interim analysis, 23 patients received RenovoGem and 22 received intravenous gemcitabine plus nab-paclitaxel.
To enroll on the study, patients were required to have histologically or cytopathologically confirmed pancreatic adenocarcinoma that was locally advanced and unresectable. Moreover, patients needed to have an ECOG performance status of 0 or 1, adequate laboratory values, and a life expectancy exceeding 12 weeks.
Those who had previously received treatment for pancreatic cancer or more than 1 cycle of treatment with gemcitabine plus nab-paclitaxel were not eligible to enroll. Additional exclusion criteria included evidence of metastatic disease or other active malignancies, an inability or unwillingness to receive first treatment within 3 weeks of post-induction imaging, or a lack of baseline tumor imaging.
“This planned, early interim data analysis is a critical look into our phase 3 randomized study. When you compare the results with other approved and widely adopted drugs used for treatment of pancreatic cancer, our 6-month median survival benefit is dramatically better than other options currently available,” Ramtin Agah, MD, chief medical officer and founder of RenovoRx, concluded.