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.

 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; 

 = .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; 

 = .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.

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Dae Won Kim, MD, discusses findings from the NAPOLI 3 trial that support the use of NALIRIFOX in patients with metastatic pancreatic cancer.

Dae Won Kim, MD

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