NALIRIFOX Regimen Improves OS in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
According to results from a phase 3 trial, use of irinotecan liposome injection in the NALIRIFOX (oxaliplatin, 5-fluorouracil, leucovorin) chemotherapy regimen was associated with a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to nab-paclitaxel plus gemcitabine for patients with previously untreated metastatic pancreatic ductal adenocarcinoma.
The open-label multi-center, phase 3 NAPOLI-3 study, enrolled 770 patients who were randomized to receive either NALIRIFOX on days 1 and 5 of each 28-day cycle or nab-paclitaxel plus gemcitabine on days 1, 8, and 15 of each 28-day cycle. The primary end point of the study was OS. Key secondary end points included PFS and safety.
According to an announcement by Ipsen, the pharmaceutical company which produces the irinotecan liposome injection, this trial met its primary end point, showing “clinically meaningful and statistically significant improvement in overall survival,” as well as a significant improvement in progression-free survival, when compared to nap-paclitaxel plus gemcitabine. The safety profile seen in trial was consistent with the previous phase 1/2 study.
A supplemental New Drug Application to the Food and Drug Administration (FDA) for this regimen in the treatment of patients with previously untreated metastatic pancreatic ductal adenocarcinoma is planned. Full clinical trial results will be presented at an upcoming oncology conference.
Source:
Onivyde regimen demonstrated statistically significant improvement in overall survival in previously untreated metastatic pancreatic ductal adenocarcinoma. News release. Ipsen US; November 9, 2022. Accessed November 10, 2022. https://www.ipsen.com/us/blog/press-releases/onivyde-regimen-demonstrated-statistically-significant-improvement-in-overall-survival-in-previously-untreated-metastatic-pancreatic-ductal-adenocarcinoma/
