Dr. Wainberg on the Rationale for the Phase 3 NAPOLI 3 Trial in Patients With PDAC

Video

In Partnership With:

Zev A. Wainberg, MD, discusses the rationale behind the phase 3 NAPOLI 3 trial in patients with metastatic pancreatic ductal adenocarcinoma.

Zev A. Wainberg, MD, professor of medicine, University of California, Los Angeles (UCLA), co-director, the UCLA GI Oncology Program, discusses the rationale behind the phase 3 NAPOLI 3 trial (NCT04083235) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

The NAPOLI 3 trial evaluated liposomal irinotecan (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (NALIRIFOX) vs nab-paclitaxel (Abraxane) plus gemcitabine. Findings presented at the 2023 Gastrointestinal Cancers Symposium showed that NALIRIFOX produced a clinically meaningful and statistically significant improvement in overall survival (OS).

At a median follow-up of 16.1 months (95% CI, 15.3-16.8), the 383 patients treated with NALIRIFOX experienced a median OS of 11.1 months (95% CI, 10.0-12.1), compared with 9.2 months (95% CI, 8.3-10.6) for the 387 patients who were given nab-paclitaxel plus gemcitabine (HR, 0.83; 95% CI, 0.70-0.99; P = .04).

With the trial, investigators attempted to provide clarity on the what should be the optimal frontline therapy regimen for metastatic pancreatic cancer, Wainberg says. The 2 regimens of FOLFIRINOX and nab-paclitaxel plus gemcitabine have been utilized for many years, but no head-to-head comparisons had been conducted , Wainberg explains.

In NAPOLI 3, investigators used NALIRIFOX, which utilized liposomal irinotecan in place of regular irinotecan, along with 5-FU, leucovorin and oxaliplatin, Wainberg continues. A previously completed a dose-escalation and -expansion study determined the optimal dosing strategy for NALIRIFOX, which was used in the randomized phase 3 NAPOLI 3 trial and compared with nab-paclitaxel plus gemcitabine, Wainberg notes.

The trial evaluated 770 patients globally in over 20 countries that help address which frontline regimen provided superiority from a survivorship perspective, Wainberg concludes.

Related Videos
Petros Grivas, MD, PhD, professor, Clinical Research Division, Fred Hutchinson Cancer Center; professor, Division of Hematology and Oncology, University of Washington (UW) School of Medicine; clinical director, Genitourinary Cancers Program, UW Medicine
Somedeb Ball, MBBS, assistant professor, medicine, Division of Hematology Oncology, Department of Medicine, Vanderbilt University Medical Center
Phillip J. Koo, MD
Gabriella Smith, MD
Mikkael A. Sekeres, MD, MS
Francesco Di Meo, PhD
Ko Un “Clara” Park, MD
Naseema Gangat, MBBS
Erin Frances Cobain, MD
Pashtoon Murtaza Kasi, MD, MS