Ipsen (OTCPK:IPSEY) (OTCPK:IPSEF) introduced full data from a phase 3 trial showing that its drug Onivyde helped enhance total survival (OS) and progression-free survival (PFS) in sufferers with a kind of pancreatic cancer.
The French drugmaker had initially reported outcomes from this examine in November 2022 noting that the trial had met its primary purpose of OS.
The examine, dubbed NAPOLI 3, evaluated Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX routine), in comparison with chemotherapies nab-paclitaxel and gemcitabine in 770 beforehand untreated sufferers with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The firm stated that on the median follow-up of 16.1 months, the Onivyde routine met its primary purpose of showing a statistically important enchancment in OS of 11.1 months in comparison with 9.2 months for sufferers handled with nab-paclitaxel and gemcitabine.
Trial met its secondary purpose showing that sufferers handled with NALIRIFOX routine had a statistically important enchancment in median PFS of seven.4 months, in comparison with 5.6 months for nab-paclitaxel and gemcitabine, in accordance with the corporate.
PFS is the size of time throughout/after therapy a affected person lives with the illness with out it getting worse.
Objective response charge (ORR) was 41.8% for sufferers handled with the NALIRIFOX routine, in comparison with 36.2% for sufferers on nab-paclitaxel and gemcitabine.
The commonest grade 3/4 treatment-emergent antagonistic occasions (TEAEs) with greater than 10% frequency in sufferers receiving NALIRIFOX, in comparison with nab-paclitaxel and gemcitabine, included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia, or low blood potassium ranges (15.1% vs 4.0%), anemia (10.5% vs 17.4%) and neutropenia, or fewer white blood cells known as neutrophils (14.1% vs 24.5%).
“In totality, the data reveal that the investigational Onivyde therapy routine (NALIRIFOX) offers a survival profit over nab-paclitaxel plus gemcitabine. We look ahead to submitting the data to the FDA,” stated Howard Mayer, govt vice chairman and head of Research and Development for Ipsen.
Ipsen famous that it plans to file a supplemental new drug software with the U.S. Food and Drug Administration in search of approval of the Onivyde routine.