IPSEY - Ipsen presents full data showing 'survival benefit' in pancreatic cancer in phase 3 trial

Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) presented full data from a phase 3 trial showing that its drug Onivyde helped improve overall survival (OS) and progression-free survival (PFS) in patients with a type of pancreatic cancer.

The French drugmaker had initially reported results from this study in November 2022 noting that the trial had met its main goal of OS.

The study, dubbed NAPOLI 3, evaluated Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen), compared to chemotherapies nab-paclitaxel and gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

The company said that at the median follow-up of 16.1 months, the Onivyde regimen met its main goal 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.

Trial met its secondary goal showing that patients treated with NALIRIFOX regimen had a statistically significant improvement in median PFS of 7.4 months, compared to 5.6 months for nab-paclitaxel and gemcitabine, according to the company.

PFS is the length of time during/after treatment a patient lives with the disease without it getting worse.

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 more than 10% frequency in patients receiving NALIRIFOX, compared to nab-paclitaxel and gemcitabine, included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia, or low blood potassium levels (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%).

"In totality, the data demonstrate that the investigational Onivyde treatment regimen (NALIRIFOX) 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 head of Research and Development for Ipsen.

Ipsen noted that it plans to file a supplemental new drug application with the U.S. Food and Drug Administration seeking approval of the Onivyde regimen.

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