Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023
- The P-III trial (NAPOLI 3) evaluating Onivyde + 5 fluorouracil/leucovorin & oxaliplatin (NALIRIFOX regimen) vs nab-paclitaxel and gemcitabine in 770 patients with mPDAC across 205 trial site locations in 18 countries
- The trial met its 1EPs i.e., the Onivyde regimen showed an improvement in OS (11.1 vs 9.2mos.) at the median follow-up of 16.1mos. NALIRIFOX regimen (liposomal irinotecan 50mg/m2 + 5-FU 2400mg/m2 + leucovorin 400mg/m2 + oxaliplatin 60mg/m2) showed an improved OS & PFS
- The trial also met its 2EPs i.e., patients with NALIRIFOX achieved improved m-PFS (7.4 vs 5.6mos.); ORR (41.8% vs 36.2%) & the safety profile was manageable & consistent with the profiles of the treatment components. The company plans to file an sNDA to the US FDA
Ref: Ipsen | Image: Ipsen
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