Disodium Folinate

Ipsen has announced that its phase 3 study of Onivyde (irinotecan liposome injection), as part of an investigational treatment regimen called Nalirifox, met its primary endpoint of improvement in overall survival (OS) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Alongside Onivyde, which the company is developing with Servier, the Nalirifox regimen contains 5-Fluorouracil, as well as oxaliplatin and leucovorin. The data from the NAPOLI 3 trial, presented by Ipsen at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, showed the novel regimen improved OS by 11.1 months compared to 9.2 months for patients treated with the standard regimen of Bristol-Myers Squibb’s Abraxane (nab-paclitaxel) plus gemcitabine. “For the first time, a clinical study in the first-line setting for metastatic pancreatic ductal adenocarcinoma demonstrated superior OS and progression-free survival (PFS) for an investigational regimen when compared to standard of care treatment with nab-paclitaxel and gemcitabine,” said Zev Wainberg, professor of medicine at UCLA and co-director of the UCLA GI Oncology Programme. PDAC is the most common type of pancreatic cancer, with approximately 60,000 people diagnosed in the US each year and nearly 500,000 people globally. Currently, fewer than 20% of patients survive for more than a year. “These findings are especially meaningful to people living with this aggressive and difficult-to-treat cancer, representing the potential to prolong life with a safety profile consistent with the safety profile of the treatment components,” Wainberg added. The trial also demonstrated a median PFS of 7.4 months in patients treated with the Nalirifox regimen versus 5.6 months for nab-paclitaxel and gemcitabine. Additionally, objective response rate was 41.8% for patients treated with Nalirifox compared to 36.2% in the standard of care group. Ipsen’s executive vice president and head of research and development, Howard Mayer, said the results were “a meaningful advance for people with previously untreated mPDAC”. Ipsen, which holds exclusive commercialisation rights for Onivyde in the US, said it plans to file a supplemental new drug application with the US Food and Drug Administration for the treatment regimen in this new use after it received fast-track designation in 2020. Onivyde is already approved in major markets, including the US and Europe, in combination with fluorouracil and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.