Multinational phase 3 trial of first-line NALIRIFOX versus nab-paclitaxel plus gemcitabine for metastatic pancreatic ductal adenocarcinoma

Patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) have a poor prognosis. The multinational phase 3 NAPOLI 3 trial evaluated first-line NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil) versus nab-paclitaxel plus gemcitabine in patients with mPDAC. Both overall survival and progression-free survival were improved with NALIRIFOX over nab-paclitaxel plus gemcitabine. Grade 3 or higher treatment-emergent adverse events occurred in 87% of patients in the NALIRIFOX group and 86% of patients in the nab-paclitaxel plus gemcitabine group. The authors conclude that these findings support use of the NALIRIFOX regimen as a possible reference regimen for first-line treatment of mPDAC.