Intra-arterial gemcitabine extends PFS in locally advanced pancreatic cancer
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Intra-arterial administration of gemcitabine conferred a median PFS benefit of 8 months when compared with standard of care for patients with locally advanced pancreatic cancer, according to results of the phase 3 TiGeR-PaC study.
The findings, presented during ESMO World Congress on Gastrointestinal Cancer, also showed a 6-month median OS benefit with intra-arterial administration of gemcitabine (RenovoGem, RenovoRx) vs. systemic chemotherapy, according to a press release from the agent’s manufacturer.
“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 has the potential to be a paradigm-shifting treatment for patients at risk [for] cancer progression, including those who have limited well-tolerated options.”
Intra-arterial administration of gemcitabine, a drug-device combination product, uses the trans-arterial microperfusion (TAMP) therapy platform to deliver gemcitabine locally across the arterial wall to bathe tumor tissue in the chemotherapy agent.
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 among patients with locally advanced pancreatic cancer.
The current analysis included 23 patients who received intra-arterial gemcitabine and 22 who received IV gemcitabine and nab-paclitaxel.
Results showed median PFS of 15 months in the investigative arm vs. 7 months in the standard-of-care arm. Additionally, patients in the investigative arm had more than a 65% reduction in adverse events vs. those in the control arm.
From the time of randomization, researchers reported median OS of 16 months in the investigative arm vs. 10 months in the control arm.
“The TIGeR-PaC study results reinforce the intended clinical advantage that TAMP brings to pancreatic cancer treatment, vs. the nontargeted approach of the current standard of care (IV) therapy,” Ramtin Agah, MD, chief medical officer of RenovoRx, said in the release. “The first look at interim analysis data of our pivotal trial supports this important advantage in overcoming the barrier of solid tumors in resisting drug uptake.”
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