Ipsen set to present five new sub-analyses of the pivotal Phase 3 NAPOLI-1 trial

Ipsen bio-pharmaceuticals set to present five new sub-analyses of the pivotal Phase 3 NAPOLI-1 trial at this year’s American Society of Clinical Oncology’s Gastrointestinal Cancer Symposium (ASCO GI) occurring in San Francisco, California, from January 18-20. The results are likely to serve as a guide to physicians scouting for treatment strategies to deal metastatic pancreatic cancer patients currently being treated with  ONIVYDE  in combination with fluorouracil (5-FU) and leucovorin (LV). There will be seven ONIVYDE poster presentations at this year’s conference.

In a randomized Phase 3 study in patients with metastatic pancreatic cancer, ONIVYDE+5-FU/LV improved overall survival (OS; primary endpoint) vs 5-FU/LV (6.1 mos vs 4.2 mos; HR = 0.67, 95% CI 0.49–0.92; P = 0.012). In a post-hoc analysis examining the impact of protocol-defined dose reductions or delays used to manage adverse events (AEs) on overall survival (OS) in ONIVYDE-treated patients, there was a numerical but not statistically significant difference in OS between patients who did have a dose reduction (patients = 34, OS = 9.3 mos) or dose delay (patients = 49, OS = 8.4 mos) vs. patients who did not require dose reductions.

Andrea Wang-Gillam, MD, PhD, Associate Professor, Divisions of Hematology and Oncology at Washington University School of Medicine. “These analyses provide physicians with additional insights on possible treatment strategies for this patient population.”

David Cox, Vice President, Global Medical Affairs – North America said “Ipsen is committed to continuing to understand the patients we serve, and it’s critical that we invest in ongoing research and additional studies that will better inform the treatment paradigm – this is particularly needed in pancreatic cancer where there are limited treatment options.”