Ipsen has recently announced the findings of the phase III NAPOLI 3 trial meeting its primary endpoint. In the trial, the NALIRIFOX regimen significantly improved overall survival in comparison to nab-paclitaxel (Abraxane) plus gemcitabine in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
PDAC is one of the most common type of cancer often detected late and after the disease has become metastatic or stage IV. Only 20% or fewer patients diagnosed with PDAC survive longer than a year, indicating the unmet therapeutic need. Onivyde is a promising drug designed to inhibit DNA replication of cancer cells and has been approved in therapeutic combinations for treating patients with metastatic adenocarcinoma of the pancreas. The NAPOLI trial has evaluated its efficacy in treating patients with PDAC.
The open-label, randomised, multicenter, phase III NAPOLI trial enrolled approximately 770 patients who did not receive prior treatment for PDAC. The participants were randomly (1:1) assigned to receive either the NALIRIFOX regimen (Onivyde plus oxaliplatin and 5-FU/leucovorin) or Abraxane plus gemcitabine. The study’s primary endpoint is overall survival (OS), and the secondary endpoints include progression-free survival (PFS), objective response rate and quality-of-life assessment.
The study meets its primary endpoint demonstrating a significant improvement in OS with the NALIRIFOX regimen in previously untreated metastatic PDAC patients. Further, a significant improvement was also in the secondary endpoint, i.e., PFS.
The findings of the NAPOLI trial clearly indicate the clinical efficacy of the NALIRIFOX regimen for PDAC patients. Based on these findings, Ipsen intends to file a supplemental new drug application to the FDA.
Onivyde regimen demonstrated statistically significant improvement in overall survival in previously untreated metastatic pancreatic ductal adenocarcinoma. News release. Ipsen Biopharmaceuticals, Inc. November 9, 2022. Accessed November 9, 2022.