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Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023

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Ipsen Presents P-III Trial (NAPOLI 3) Results of Onivyde for Metastatic Pancreatic Ductal Adenocarcinoma at ASCO GI 2023

Shots:

  • 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

Related News:- Ipsen Reports P-III (NAPOLI 3) Trial Results of Onivyde for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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