*NALIRIFOX for 1L PDAC Phase III trial has achieved Primary Endpoint Overall Survival and Key Secondary Endpoint Progression Free Survival.

*NALIRIFOX Showed a Safety and Tolerability Profile Consistent with Prior Clinical Study.

*Ipsen intends file an application for NALIRIFOX with the U.S. FDA, following a previous fast-track designation granted in 2020.

 

PharmaEngine's corporate partner, IPSEN (Euronext: IPN; ADR: IPSEY) has announced that the Phase III NAPOLI-3 trial comparing the NALIRIFOX regimen (ONIVYDE® plus fluorouracil (5-FU)/leucovorin (LV) plus oxaliplatin) to nab-paclitaxel plus gemcitabine in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) met its primary endpoint of improving overall survival (OS). The key secondary efficacy outcome of progression-free survival (PFS) was also improved vs. the comparator arm, and the safety profile was consistent with that observed in the previous phase I/II mPDAC study. The detailed of clinical trial results will be presented at an upcoming medical conference.

 

Based on these clinically meaningful and statistically significant results, IPSEN intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for NALIRIFOX for the treatment of patients with previously untreated mPDAC following the Fast Track Designation granted in 2020.

 

For further information regarding IPSEN's press release, please refer to the following link https://www.ipsen.com/press-release/