On March 8, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported promising interim data in the Phase III open label TIGeR-PaC clinical trial (Press release, Renovorx, MAR 8, 2023, View Source [SID1234628366]). The study is investigating the Company’s first product candidate, RenovoGem, as a potential treatment option in locally advanced pancreatic cancer ("LAPC").
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The interim analysis suggests a 6-month potential improvement in median overall survival with RenovoGem, pending ongoing clinical investigation. 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 stereotactic body radiation therapy ("SBRT"). The study compares treatment with RenovoTAMP versus standard of care systemic intravenous ("IV") administration of gemcitabine and nab-paclitaxel, which has a seven-week survival benefit and $1 billion addressable market.
This first-of-two interim analyses indicates that the TIGeR-PaC study is on track to demonstrate increased lifespan for patients being treated with RenovoGem for LAPC. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: this first analysis with 30% of the specified events (deaths) reported and the second analysis when 60% of the events have been reported (expected in 2024).
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.
23 patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (control or standard of care) arm. There were an equal number of primary events, 13 in each 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. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life since diagnosis 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).
"We are pleased with the promising readout of our study’s first interim analysis, and we extend our sincere and continued strong appreciation to all the patients, investigators, and team members involved in reaching this important milestone," said Shaun Bagai, CEO of RenovoRx. "Based on these data, we will continue our ongoing clinical trial to collect more data to support our new drug application. Our team intends to engage further with the FDA to facilitate an expeditious path forward for our treatment platform."
Bagai added, "Our mission is to transform the current standard of care for patients diagnosed with difficult-to-treat cancers, such as LAPC. The trend has been to layer additional drugs to the current standard of care that can double, triple, or quadruple, drug regimen for these patients. Our vision is to greatly improve existing treatment drugs by focusing on their targeted delivery to tumors, and, ultimately, improve quality of life and survival."
TIGeR-PaC Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, "Results from the interim analysis echo those of the Phase I/II and observational studies. The data suggests that RenovoGem has the potential to enhance patient survival. This is important because treatment of locally advanced pancreatic cancer is often limited to systemic, high dose IV chemotherapy treatment, which often comes with debilitating side effects to patients."
Dr. Pishvaian added, "Importantly, these results provide hope for a potentially improved, compelling new treatment option for this important patient population. If study data continues to trend positive, the RenovoGem platform holds promise for expanding to other indications, including other cancers and/or more advanced stages of cancer."
Full data from the first interim analysis of the TIGeR-PaC study will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 17, 2023, in Orlando, Florida.
TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source
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.