NAPOLI-3 — NALIRIFOX Versus Gemcitabine Plus Nab-Paclitaxel as First-Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma

Phase 3 · 2023 · Pancreatic Cancer

Design

Randomized open-label phase 3 comparing NALIRIFOX (liposomal irinotecan + oxaliplatin + leucovorin + 5-FU) versus gemcitabine plus nab-paclitaxel as first-line therapy for metastatic PDAC.

Population

Untreated metastatic pancreatic ductal adenocarcinoma, ECOG performance status 0-1.

Primary Endpoint

overall survival (OS)

Key Result

OS 11.1 vs 9.2 mo (HR 0.83, P=0.036); PFS 7.4 vs 5.6 mo (HR 0.69); NALIRIFOX established as a first-line cytotoxic backbone.

Guideline Impact

NCCN-listed first-line regimen for metastatic pancreatic adenocarcinoma (ECOG 0-1)