According to results of the phase III TIGeR-PaC study, intra-arterial administration of gemcitabine conferred a median PFS benefit of eight months when compared with standard-of-care for patients with locally advanced pancreatic cancer (PCa).
According to a press release from the agent’s manufacturer, the results presented at ESMO World Congress on Gastrointestinal Cancer 2023, also exhibited a 6-month median OS benefit with intra-arterial administration of gemcitabine (RenovoGem, RenovoRx) vs. systemic chemotherapy.
“Clinical practice has been waiting decades for a meaningful advancement in the standard-of-care for pancreatic cancer treatment, with less toxicity and better outcomes,” Michael J. Pishvaian, MD, PhD, principal investigator of the TIGeR-PaC study, said in a press release. “These data have the potential to be a paradigm-shifting treatment for patients at risk for cancer progression, including those who have limited well-tolerated options.”
In order to immerse tumour tissue in the chemotherapy agent, intra-arterial administration of gemcitabine uses the trans-arterial micro-perfusion (TAMP) therapy platform to deliver gemcitabine locally across the arterial wall. In a patient population with locally advanced pancreatic cancer (PCa), the TIGeR-PaC study assessed the efficacy and safety of intra-arterial gemcitabine vs. standard-of-care IV gemcitabine and nab-paclitaxel after upfront induction chemotherapy and stereotactic body radiation therapy. The study included 23 patients who received intra-arterial gemcitabine and 22 who received IV gemcitabine and nab-paclitaxel.
Results showed a median PFS of fifteen months in the investigative arm vs. seven months in the standard-of-care arm. Patients in the investigative arm had a more than 65% reduction in adverse events vs. those in the control arm. From the time of randomisation, researchers reported a median OS of sixteen months in the investigative arm vs. ten months in the control arm. “The TIGeR-PaC study results reinforce the intended clinical advantage that TAMP brings to PCa treatment, vs. the non-targeted approach of the current standard-of-care (IV) therapy,” Ramtin Agah, MD, chief medical officer of RenovoRx, said in the press release. “The first look at interim analysis data of our pivotal trial supports this important advantage in overcoming the barrier of solid tumours in resisting drug uptake”.1