Dr Rogers on the NEO-Nal-IRI Trial in Pancreatic Adenocarcinoma

Sherise Rogers, MD, MPH, an assistant professor of Hematology/Oncology at University of Florida Health (UFH), Division of Hematology and Oncology, Department of Medicine in the College of Medicine, discusses the rationale for investigating irinotecan liposome injection (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (NALIRIFOX) in the preoperative treatment of patients with pancreatic adenocarcinoma.

At the 2023 ASCO Annual Meeting, Rogers and colleagues shared the rationale for investigating NALIRIFOX in the ongoing phase 2 NEO-Nal-IRI trial (NCT03483038), which is evaluating its safety and activity in patients with newly diagnosed borderline resectable or resectable pancreatic cancer without overt metastatic disease.

Findings from the phase 3 NAPOLI 3 trial (NCT04083235) demonstrated that NALIRIFOX produced a clinically meaningful and statistically significant improvement in overall survival (OS) vs nab-paclitaxel (Abraxane) plus gemcitabine in the first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDAC). In June 2023, the FDA accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen as a first-line treatment for patients with metastatic (PDAC).

Based on these promising outcomes, the phase 2 NEO-Nal-IRI will evaluate NALIRIFOX as a novel regimen in the neoadjuvant setting, Rogers says. Investigators are excited to better understand if this approach may improve postoperative complication rates, she explains, noting that the primary objectives of this ongoing study are safety and feasibility.

The hope for this trial is to further address the unmet needs that remain in the treatment landscape for patients with pancreatic cancer, she continues. Overall, pancreatic cancer has a very dismal prognosis with a low OS rate, creating the desperate need of new therapies to improve these outcomes in patients, she concludes.

Enrollment for NEO-Nal-IRI has been completed, and no unexpected toxicities have been reported thus far. Primary results are anticipated in 2024.