Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) said its drug Onivyde met the main goal of overall survival in patients with pancreatic cancer in a phase 3 trial.
The study, dubbed NAPOLI 3, evaluated Onivyde (irinotecan liposome injection) plus the NALIRIFOX regimen (5 fluorouracil/leucovorin and oxaliplatin), compared to chemotherapies nab-paclitaxel and gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The French drugmaker said the study met its main goal as Onivyde plus NALIRIFOX regimen showed a clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine.
The company added that key secondary efficacy goal of progression-free survival (PFS - length of time during/after treatment a patient lives with the disease without it getting worse) also showed significant improvement over the comparator group.
The safety profile of Onivyde in the study was consistent with those seen in previous phase 1/2 mPDAC study, the company noted.
Ipsen said it intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for the Onivyde combo to treat patients with previously untreated mPDAC.
Onivyde is currently approved in the U.S. in combination with fluorouracil (5-FU) and leucovorin to treat patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
"The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated," said Howard Mayer, executive vice president and head of Research and Development for Ipsen.
In August, Onivyde had failed a phase 3 trial in patients with a type of lung cancer as it did not meet the main goal of overall survival versus Novartis' Hycamtin (topotecan).
For further details see:
Ipsen Onivyde combo meets trial's survival goal in untreated pancreatic cancer patients