NALIRIFOX Worth Consideration in Pancreatic Ductal Adenocarcinoma, Says Expert

An expert from the University of California, Los Angeles suggests that the NALIRIFOX may be a beneficial treatment for patients with pancreatic ductal adenocarcinoma.

First-line liposomal irinotecan (Onivyde) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX), if approved by the FDA, should considered as a treatment option for average patients with metastatic pancreatic ductal adenocarcinoma, according to Zev. A. Wainberg, MD.

CancerNetwork® spoke with lead author, Wainberg, a professor of medicine at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal Oncology Program, about his takeaways from the phase 3 NAPOLI-3 study (NCT04083235), the data from which he presented at the 2023 Gastrointestinal Cancers Symposium.

In particular, he noted that meeting end points in pancreatic cancer trials has been a historical challenge, and that the positive findings from the NAPOLI-3 trial should be considered despite not being as impressive as originally hoped. Additionally, the trial answered an important question regarding the NALIRIFOX’s superiority.


We answered a question for the community, and it’s important to do that; it’s important to answer questions as to what the optimal regimen in a disease like metastatic pancreatic cancer. In this trial, we certainly did answer this question conclusively: NALIRIFOX is superior to gemcitabine and nab-paclitaxel for overall survival and with a different trade-off in toxicity.

For an average patient with an ECOG performance status of 0 [or] 1, this regimen, if approved, should be considered. It’s very hard to prove your end point of overall survival in pancreatic cancer studies; it has been done rarely throughout the history of this disease. When it does happen, even if the results were not as, in some ways, exciting as many of us would have hoped, we need to take those results in mind.


Wainberg ZA, Melisi D, Macarulla T, et al. NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). J Clin Oncol. 2023;41(suppl 4):LBA661. doi:10.1200/JCO.2023.41.3_suppl.LBA661

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