Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI
PARIS, FRANCE, January 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® (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 + 5-FU 2400 mg/m2 + leucovorin 400 mg/m2 + oxaliplatin 60 mg/m2) improved overall survival (OS) and progression-free survival (PFS) compared to nab-paclitaxel plus gemcitabine.1 At 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 0.70–0.99]; p=0.04).1†
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