RenovoTAMP Supports Gemcitabine Delivery and Decreases AEs in Pancreatic Cancer

A substudy of the TIGeR-PaC trial showed that treatment with RenovoTAMP may increase local gemcitabine delivery and decrease the debilitating adverse events associated with intravenous administration in pancreatic cancer.

Patients with locally advanced pancreatic cancer administered RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) had a 50% reduction in systemic drug exposure with intra-arterial (IA) delivery of gemcitabine vs intravenous (IV) administration.1

These initial findings come from a substudy evaluating pharmacokinetics within the phase 3 TIGeR-PaC trial (NCT03257033).1 In this substudy, investigators evaluated 13 patients with pancreatic cancer at 5 TIGeR-PaC clinical sites.

Results showed that treatment with RenovoTAMP may increase local gemcitabine concentration. Though systemic IV delivery is the current standard of care for these patients, it often is accompanied by debilitating adverse events (AEs).

These findings support the potential of RenovoTAMP in increasing local drug delivery and concentration at the tumor site while decreasing AEs.

"The upcoming presentation of our TIGeR-PaC clinical trial substudy at ASCO GI highlights significant potential benefits for patients with [locally advanced pancreatic cancer]," said Ramtin Agah, MD, chief medical officer and founder of RenovoRx, in the press release. "Targeted local delivery of standard dose gemcitabine via the RenovoTAMP therapy platform may be associated with significantly less systemic drug exposure. The clinical implications may be decreased side effects and enhanced chemotherapy delivery. Ongoing studies are quantifying the resulting impact on improving patients’ quality of life and extending lifespan."

The multi-center, un-blinded, randomized TIGeR-PaC clinical trial is assessing IA administration of gemcitabine using the proprietary RenovoTAMP compared with IV administration for targeted treatment of patients with locally advanced pancreatic cancer.2

All patients enrolled will receive induction therapy of IV gemcitabine plus nab-paclitaxel and radiation therapy for approximately 4 months. Then, patients who remain eligible will be randomized and given either IA chemotherapy with gemcitabine or to continue gemcitabine plus nab-paclitaxel.

Patients will receive randomized treatments for up to 16 weeks or until progression, and both cohorts will receive either treatment following 16 weeks until disease progression at the discretion of the investigator.

The trial will enroll approximately 320 patients aged 18 years and older with histologically or cytopathology confirmed pancreatic adenocarcinoma that is locally advanced with unresectable disease at the time of screening and prior to randomization. Patients must have an ECOG performance status 0 or 1, adequate laboratory values prior to starting the first dose of nab-paclitaxel and gemcitabine, and a life expectancy of greater than 12 weeks.

The primary end point of the trial is overall survival with secondary end points of overall survival, progression-free survival, objective response rate, health related quality-of-life, neuropathy assessment, frequency of neutropenia, patient reported symptoms, and safety.

At the 2023 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO GI), 3 additional abstracts will be presented supporting the use of RenovoTAMP with gemcitabine for treatment of patients with locally advanced pancreatic cancer.

"This substudy data, and the additional three studies to be presented at ASCO GI, enhance the strong clinical momentum of our therapy platform as we prepare for our most significant milestone to date: the initial interim analysis for our randomized phase 3 TIGeR-PaC trial." said Shaun Bagai, chief executive officer of RenovoRx, in the press release.

REFERENCES:
RenovoRx announces initial results in pharmacokinetic (PK) substudy: data on RenovoGem™ supports potential for RenovoTAMP® therapy platform to increase local gemcitabine (chemotherapy) delivery and decrease side effects of pancreatic cancer treatment. News release. RenovoRx, Inc. January 18, 2023. Accessed January 19, 2023. https://yhoo.it/3Xl4suT
Intra-arterial gemcitabine vs. IV gemcitabine and nab-paclitaxel following radiotherapy for LAPC (TIGeR-PaC). ClinicalTrials.gov. Updated February 25, 2022. Accessed January 19, 2023. https://clinicaltrials.gov/ct2/show/NCT03257033