gorodenkoff
Ipsen (OTCPK:IPSEY) (OTCPK:IPSEF) presented complete data from a Phase 3 trial showing that its drug Onivyde helped improve overall survival (OS) and progression-free survival (PFS) in patients with one type of pancreatic cancer.
The French pharmaceutical had initially reported The results of this study in November 2022 indicated that the trial had met its primary objective of OS.
The study, called NAPOLI 3, evaluated Onivyde (irinotecan liposome injection) plus 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen), compared with nab-paclitaxel and gemcitabine chemotherapies in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma ( mPDAC).
The company said that at a median follow-up of 16.1 months, the Onivyde regimen met its primary endpoint of showing a statistically significant improvement in OS of 11.1 months compared to 9.2 months for patients treated with nab-paclitaxel and gemcitabine.
The trial met its secondary endpoint, showing that patients treated with the NALIRIFOX regimen had a statistically significant improvement in median PFS of 7.4 months, compared with 5.6 months for nab-paclitaxel and gemcitabine, according to the company. .
PFS is the time during/after treatment that a patient lives with the disease without getting worse.
The objective response rate (ORR) was 41.8% for patients treated with the NALIRIFOX regimen, compared to 36.2% for patients on nab-paclitaxel and gemcitabine.
The most common Grade 3/4 treatment-emergent adverse events (TEAEs) with a frequency greater than 10% in patients receiving NALIRIFOX, compared with nab-paclitaxel and gemcitabine, included diarrhea (20.3% vs 4.5%). %), nausea (11.9% vs. 2.6%), hypokalemia or low blood potassium (15.1% vs. 4.0%), anemia (10.5% vs. 17.4%) ) and neutropenia, or fewer white blood cells called neutrophils (14.1% vs. 24.5%).
“Taken together, the data demonstrate that the investigational Onivyde (NALIRIFOX) treatment regimen provides a survival benefit over nab-paclitaxel plus gemcitabine. We look forward to submitting the data to the FDA,” said Howard Mayer, executive vice president and chief executive officer research. and Development for Ipsen.
Ipsen said he plans to file a new supplemental drug application with the US Food and Drug Administration to get approval for the Onivyde regimen.
