{"id":1620,"date":"2023-01-20T08:00:00","date_gmt":"2023-01-20T07:00:00","guid":{"rendered":"https:\/\/d36deud6t4mnhi.cloudfront.net\/annualreport\/press-releases\/ipsen-presents-phase-iii-napoli-3-trial-of-onivyde-regimen-demonstrating-positive-survival-results-in-previously-untreated-metastatic-pancreatic-ductal-adenocarcinoma-at-asco-gi\/"},"modified":"2023-05-23T14:11:18","modified_gmt":"2023-05-23T14:11:18","slug":"ipsen-presents-phase-iii-napoli-3-trial-of-onivyde-regimen-demonstrating-positive-survival-results-in-previously-untreated-metastatic-pancreatic-ductal-adenocarcinoma-at-asco-gi","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/annualreport\/press-releases\/ipsen-presents-phase-iii-napoli-3-trial-of-onivyde-regimen-demonstrating-positive-survival-results-in-previously-untreated-metastatic-pancreatic-ductal-adenocarcinoma-at-asco-gi\/","title":{"rendered":"Ipsen presents Phase III NAPOLI 3 trial of Onivyde\u00ae regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI"},"content":{"rendered":"
PARIS, FRANCE,<\/strong>\u00a0January 20, 2023, Ipsen (Euronext: IPN; ADR: IPSEY) today presented positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde\u00ae<\/sup>\u00a0(irinotecan liposome injection), a long-circulating, liposomal topoisomerase inhibitor, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In a late-breaking abstracts session presentation (LBA661) at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, the data demonstrating investigational novel NALIRIFOX regimen (liposomal irinotecan 50 mg\/m2<\/sup>\u00a0+ 5-FU 2400 mg\/m2<\/sup>\u00a0+ leucovorin 400 mg\/m2<\/sup>\u00a0+ oxaliplatin 60 mg\/m2<\/sup>) improved overall survival (OS) and progression-free survival (PFS) compared to nab-paclitaxel plus gemcitabine.1<\/sup>\u00a0At the median follow-up of 16.1 months, the investigational Onivyde regimen met its primary endpoint demonstrating a statistically significant improvement in OS of 11.1 months compared to 9.2 months for patients treated with nab-paclitaxel and gemcitabine (HR 0.83 [95% CI 0.70\u20130.99]; p=0.04).1\u2020<\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[],"tags":[],"class_list":["post-1620","press_release","type-press_release","status-publish","hentry","entry"],"acf":[],"yoast_head":"\n