Onivyde regimen extends OS in metastatic pancreatic ductal adenocarcinoma
An irinotecan liposome injection regimen improved OS compared with standard chemotherapy among untreated patients with metastatic pancreatic ductal adenocarcinoma, according to the agent’s manufacturer.
Irinotecan liposome injection (Onivyde, Ipsen) is a long-circulating liposomal topoisomerase inhibitor designed to interrupt DNA replication in cancer cells.
Irinotecan liposome injection enters cancer cells using a naturally occurring process and, as macrophages unpack the liposomes, activates to facilitate the release of the cytotoxic payload into the tumor, according to an Ipsen-issued press release.
The agent is approved in the United States for use in combination with 5-FU and leucovorin for treatment of patients with metastatic adenocarcinoma of the pancreas whose disease progressed after gemcitabine-based therapy.
The randomized phase 3 NAPOLI 3 trial included 770 treatment-naive patients with metastatic pancreatic ductal adenocarcinoma.
Researchers assigned patients to an experimental regimen — irinotecan liposome injection plus oxaliplatin and 5-FU/leucovorin twice a month (days 1 and 15 of a 28-day cycle) — or standard chemotherapy, which consisted of an injection of nab-paclitaxel and gemcitabine administered three times a month (days 1, 8 and 15 of a 28-day cycle).
The study met its primary endpoint of longer OS with the irinotecan liposome injection regimen. The study also met a key secondary efficacy outcome of longer PFS in the experimental group.
Irinotecan liposome injection exhibited a safety profile consistent with that observed in a previous phase 1/phase 2 study of patients with metastatic pancreatic ductal adenocarcinoma.
“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,” Howard Mayer, MD, executive vice president and head of research and development for Ipsen, said in the press release. “The prognosis for people diagnosed with pancreatic cancer is extremely poor, and we plan to submit these new findings to the regulatory authority as, if approved, we believe this regimen could offer up an important new treatment option for people living with an aggressive and hard-to-treat cancer.”
Complete data from NAPOLI 3 will be presented at a medical conference.
Read more about