RenovoRx’s RenovoTAMP Pancreatic Cancer Therapy Platform Evaluated in Pharmokinetic Substudy of TIGeR-PaC Trial

January 25, 2023—RenovoRx, Inc. recently announced initial results from a pharmacokinetic (PK) substudy within the phase 3 TIGeR-PaC study.

TIGeR-PaC is an unblinded randomized multicenter phase 3 clinical trial evaluating intra-arterial administration of RenovoGem (gemcitabine) chemotherapy using the company’s RenovoRx transarterial microperfusion (RenovoTAMP) platform for targeted treatment of locally advanced pancreatic cancer (LAPC) after stereotactic body radiation therapy (SBRT).

The RenovoRx treatment uses pressure-mediated delivery of the FDA-approved RenovoGem drug across the arterial wall to bathe tumor tissue in chemotherapy via RenovoTAMP. The company was granted FDA Orphan Drug designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma).

The findings from the study, “Intra-arterial Gemcitabine vs Intravenous Gemcitabine PK Substudy in Patients with Locally Advanced Pancreatic Cancer,” by Amer H. Zureikat, MD, et al, were presented at the American Society of Clinical Oncology’s Gastrointestinal Cancers (ASCO GI) symposium held on January 19-21 in San Francisco, California.

Three additional abstracts supporting the use of RenovoTAMP with gemcitabine for treatment of LAPC were also presented at the ASCO GI symposium. The poster presentations for the four RenovoRx abstracts from the symposium are available on RenovoRx’s website at https://renovorx.com/for-clinicians/.

According to the company, the PK substudy provides clinical support that RenovoTAMP for intra-arterial delivery may increase local drug delivery and thus concentration at the tumor site while decreasing the debilitating side effects often associated with systemic intravenous delivery, which is the current standard of care.

The PK substudy evaluated a sample of LAPC patients (n = 13) from five clinical sites participating in the TIGeR-PaC study and demonstrated that the cohort had an average > 50% reduction in systemic drug exposure with intra-arterial delivery of gemcitabine using RenovoTAMP when compared with intravenous administration. The study concluded that RenovoTAMP may increase local gemcitabine concentration, which may be beneficial in decreasing gemcitabine-related systemic side effects.

Additionally, the company outlined the three additional ASCO GI 2023 abstracts as follows:

• Amer H. Zureikat, MD, et al investigated mesenteric venous thrombosis (MVT), which is often identified on routine imaging studies performed with LAPC, and concluded that severe MVT is more prevalent in this patient population than previously reported. Anticoagulation is also underused in this cohort; however, chemotherapy may have a beneficial effect in downstaging MVT beyond anticoagulation.
• Karyn A. Goodman, MD, et al performed an exploratory analysis to compare the toxicity and efficacy between patients receiving either SBRT or intensity-modulated radiation therapy (IMRT) during the induction phase (before randomization) of the TIGeR-PaC study. When compared to IMRT, SBRT demonstrated improved tolerability for treatment of patients with LAPC with comparable clinical efficacy. The company noted that this finding led to the modification of the TIGeR-PaC study design in 2021.
• Michael J. Pishvaian, MD, et al focused on the TIGeR-PaC trial design and status.

The company advised that TIGeR-PaC has a primary endpoint of overall survival and several secondary endpoints, including quality of life. The study is designed to randomize 114 patients with all patients receiving upfront SBRT and induction chemotherapy and 57 patients in each arm. Final analysis will be conducted after 86 deaths from the SBRT population. Additionally, the study includes two planned interim analyses, the first on 30% (26 of 86) of the total and the second on 60% (52 of 86) of the total.

To date, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC trial, and the company has received reports of 25 events (deaths) in this population.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the United States. More information about the study and the clinical trial sites is available at the company’s clinical trial site, https://renovorx.com/clinical-trial/.

In addition to the phase 3 clinical trial in LAPC patients, the company plans to investigate RenovoGem in extrahepatic cholangiocarcinoma beginning in the first half of 2023.