On March 30, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that it will present detailed, open label, planned Phase III interim data analysis of its innovative RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 17, 2023 in Orlando, Florida (Press release, Renovorx, MAR 30, 2023, View Source [SID1234629683]).
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The interim analysis shows a 6-month median overall survival benefit for patients. That is nearly a 60% improvement versus the study control arm and current standard of care: intravenous (IV) administration of gemcitabine and nab-paclitaxel for locally advanced pancreatic cancer ("LAPC"). RenovoGem patients also had greater than 65% reduction in adverse events. These can include nausea, fatigue, and a decline in white blood cells.
TIGeR-PaC study Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, "Results from the interim analysis echo the Phase I/II data and observational studies. The TIGeR-PaC clinical trial is ongoing, but it appears RenovoGem enhances patient survival and has fewer side effects than the standard of care treatment that impacts the entire body of a patient rather than the targeted treatment area. This is important because treatment of LAPC is often limited to systemic, high dose, IV chemotherapy. It often has debilitating side effects."
Dr. Pishvaian added, "These positive results offer hope for a compelling new treatment option that could greatly benefit this important patient population and perhaps many others as the research advances."
Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx, said, "This planned, early interim data analysis is a critical look into our Phase III randomized study. When you compare the results with other approved and widely adopted drugs used for treatment of pancreatic cancer, our six-month median survival benefit is dramatically better than other options currently available. It is worth noting that ten years ago, Celgene announced positive, Phase III trial results for pancreatic cancer patients. Its Abraxane drug, plus gemcitabine, provided an overall survival benefit of seven weeks."
"As a result, we will be advancing discussions with the FDA about expediting forward progress, while continuing our current trial enrollment," said Dr. Agah.
RenovoRx CEO, Shaun Bagai, commented, "We are more than a third way through our Phase III TIGeR-PaC study and are encouraged by these data. Every extra day these patients enjoy is invaluable. With decreased adverse events, the six-month survival benefit we are reporting is even more profound."
Mr. Bagai added, "We believe the current standard of care needs a disruptive therapy like RenovoGem. There is a growing consensus our platform has the potential to impact other cancers and more advanced cancer stages. Consequently, we are evaluating RenovoGem for additional indications and having ongoing discussions with possible strategic partner oncology companies."
About TIGeR-PaC Interim Analysis Data
TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat LAPC following SBRT. The study is comparing treatment with RenovoGem versus standard of care treatment.
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 (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. The TIGeR-PaC Data Monitoring Committee ("DMC") 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 survival status of all subjects was used for the analysis.
Twenty-three patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (standard of care control) 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. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial).
Observed a positive trend in median overall survival by 24-weeks (6 months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).
Observed that patients had greater than 65% reduction in adverse events compared to the control arm: In the IV gemcitabine and nab-paclitaxel control arm there were 11 reported Serious Adverse Events (out of 22 patients) vs. 4 reported Serious Adverse Events (out of 23) intra-arterial RenovoGem patients.
The second interim analysis of this Phase III trial is expected in mid-2024.
About Locally Advanced Pancreatic Cancer (LAPC)
According to American Cancer Society’s Cancer Facts & Figures 2023, Pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.
About RenovoGem
RenovoGem is the first drug-device combination product candidate that utilizes the RenovoTAMP therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved systemic chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.