Positive Topline Results from Phase III NAPOLI-3 trial of ONIVYDE® regimen (NALIRIFOX) as a first-line treatment for previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)

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

About NAPOLI-3 trial

NAPOLI-3 is a randomized, open-label Phase III trial of ONIVYDE® treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma. ONIVYDE® plus oxaliplatin and 5 -FU/LV was administered twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine administered three times a month (days 1, 8, 15 of a 28-day cycle). Approximately 770 patients were enrolled in the trial with the primary outcome measure of overall survival. Secondary outcome measures included progression-free survival, objective response rate, quality of life assessment, incidence of treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Adverse events and laboratory analyses were also analyzed.


ONIVYDE, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. PharmaEngine, Inc. has Taiwan exclusive commercial rights, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the US exclusive new indication development and commercial rights, the exclusive rights for rest of the world are owned by Servier. ONIVYDE® has been approved in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with mPDAC after disease progression following gemcitabine-based therapy in Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China since 2011. It also received orphan drug designations in the US, EU, and other countries.

About Pancreatic Ductal Adenocarcinoma (PDAC)

PDAC is the most common and aggressive type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in all stages, the majority of patients have unresectable, locally advanced, or metastatic disease at the time of diagnosis.. Currently, fewer than 20% survive longer than one year, making survival a crucial trial endpoint and overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

About PharmaEngine, Inc. (TWO: 4162)

PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, focusing on the development of new medications for the treatment of cancer. PharmaEngine, Inc. has two ongoing projects: ONIVYDE® (Irinotecan Liposome Injection) has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China, for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine; PEP07, a CHK1 inhibitor, is under development at IND ready stage. For further information, please visit the company website (


Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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