Dr Kim on the Addition of NALIRIFOX to the Pancreatic Cancer Treatment Paradigm

Dae Won Kim, MD, Gastrointestinal Oncology Program, Moffitt Cancer Center, discusses findings from the phase 3 NAPOLI 3 trial (NCT04083235) that support the use of NALIRIFOX (irinotecan liposome [Onivyde], oxaliplatin, 5-fluorouracil, and leucovorin) in patients with metastatic pancreatic cancer.

On February 13, 2024, the FDA approved NALIRIFOX for the frontline treatment of patients with metastatic pancreatic adenocarcinoma. This regulatory decision was supported by findings from the NAPOLI 3 trial, in which NALIRIFOX elicited a median overall survival (OS) of 11.1 months (95% CI, 10.0-12.1) compared with 9.2 months (95% CI, 8.3-10.6) with gemcitabine plus nab-paclitaxel (Abraxane; HR, 0.84; 95% CI, 0.71-0.99; P = .0403). The median progression-free survival (PFS) was 7.4 months (95% CI, 6.0-7.7) with NALIRIFOX vs 5.6 months (95% CI, 5.3-5.8) with gemcitabine plus nab-paclitaxel (HR, 0.70; 95% CI, 0.59-0.85; P = .0001). Furthermore, the overall response rate (ORR) with NALIRIFOX was 41.8% (95% CI, 36.8%-46.9%) vs 36.2% (95% CI, 31.4%-41.2%) with the control regimen.

Available first-line treatment options for patients with metastatic pancreatic cancer include gemcitabine with or without nab-paclitaxel, FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin), and NALIRIFOX, Kim says. The NAPOLI 3 trial demonstrated a significant OS improvement with NALIRIFOX compared with gemcitabine plus nab-paclitaxel, as well as improvements in other clinical outcomes, such as ORR, Kim notes. Although these data support the use of NALIRIFOX over gemcitabine plus nab-paclitaxel, head-to-head comparisons of NALIRIFOX vs FOLFIRINOX in patients with pancreatic cancer have yet to be conducted, Kim emphasizes. Thus, data do not currently support the use of 1 regimen over the other, Kim explains. However, the NAPOLI 3 data show that patients with metastatic disease with a good ECOG performance status (PS) may benefit from treatment with NALIRIFOX instead of gemcitabine plus nab-paclitaxel, Kim concludes. NAPOLI 3 enrolled patients with an ECOG PS of 0 or 1.