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†