NALIRIFOX regimen improves OS and PFS in patients with metastatic PDAC

February 2023 Pharma News Nalinee Pandey

The pharmaceutical company Ipsen recently announced that Onivyde® (irinotecan liposome injection), when used as part of an investigational NALIRIFOX regimen, extends overall survival in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Based on these findings, the company plans to apply for FDA approval for the new NALIRIFOX treatment regimen in the first-line setting.

Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, being one of the leading causes of cancer-related deaths. No significant treatment advancement was reported in the last decades for metastatic PDAC patients, reflecting this dreaded disease’s poor treatment landscape. The encouraging findings with Onivyde in the NAPOLI 3 trial represent a significant advancement in metastatic PDAC treatment and a new ray of hope for patients suffering from this deadly disease.

Study findings

The open-label, randomised NAPOLI phase III trial recruited 770 PDAC patients who had no prior treatment in the metastatic setting. The participants were randomly (1:1) allocated to either the NALIRIFOX regimen (Onivyde plus 5- fluorouracil/leucovorin and oxaliplatin, n=383) or nab-paclitaxel plus gemcitabine (Gem-NabP, n=387). The primary and secondary endpoints were overall survival (OS) and progression-free survival (PFS).

Patients in the NALIRIFOR regimen had significantly longer OS (11.1 months) than those in the Gem-NabP arm (9.2 months, HR[95%CI]: 0.83[0.70-0.99]; p=0.04). Similarly, the median PFS was longer in the NALIRIFOX arm vs. Gem-NabP (7.4 vs. 5.6 months, HR[95%CI]: 0.69[0.58-0.83]; p<0.0001). A similar trend was seen in the objective response rate (41.8% vs. 36.2%).

The safety profile of NALIRIFOX was manageable and consistent with treatment components. The most common grade 3/4 treatment-related adverse events with NALIRIFOX were non-haematological malignancies such as diarrhoea, nausea, hypokalaemia, anaemia and neutropenia.


The NALIRIFOX regimen is a significant milestone for metastatic PDAC patients. Hopefully, this would be a starting point for more efficient treatment regimens in the near future.


Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI. Press release. 2023.