Ipsen’s irinotecan liposome injection shows significant OS in pancreatic cancer patients during trial
French biopharmaceutical major Ipsen has announced recently that its investigational anticancer drug irinotecan liposome injection, marketed as Onivyde, has shown statistically significant overall survival in metastatic pancreas patients during the trial.
Announcing the trial findings, Ispsen said in a media statement that at the median follow-up of 16.1 months, the investigational irinotecan liposome injection regimen met its primary objective by demonstrating a statistically significant improvement in OS of 11.1 months compared to 9.2 months for patients treated with nab-paclitaxel and gemcitabine.
It may be recalled that the drug was approved by the United States Food and Drug Administration (USFDA) in October 2015 for treating patients with metastatic pancreatic cancer whose disease has progressed after gemcitabine-based chemotherapy.
Commenting on the trial findings, Dr Zev Wainberg, Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program, said, “For the first time, a clinical study in the first-line setting for metastatic pancreatic ductal adenocarcinoma demonstrated superior overall survival and progression-free survival for an investigational regimen when compared to standard of care treatment with nab-paclitaxel and gemcitabine.”
“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,” he added.
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Pointing out that very few clinical studies in metastatic pancreatic ductal adenocarcinoma have demonstrated efficacy in the past few decades, Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen, said, “Progress has been slow with limited treatment options, hence, the NAPOLI 3 results are a meaningful advance for people with previously untreated metastatic pancreatic ductal adenocarcinoma.”
Stating that the company will share the data with the USFDA, he added, “In totality, the data demonstrate that the investigational Onivyde treatment regimen (Nalirifox) provides a survival benefit over nab-paclitaxel plus gemcitabine.”
Ipsen stated that it is planning to file a supplemental New Drug Application with the USFDA for Onivyde in combination with oxaliplatin plus 5- fluorouracil or leucovorin for the treating previously untreated metastatic pancreatic following the Fast Track Designation granted by the drug regulator in 2020.
Onivyde is a cancer treatment that inhibits an enzyme called topoisomerase I, which is involved in the copying of cell DNA required to create new cells. Cancer cells are prevented from multiplying and eventually die when the enzyme is blocked. Irinotecan is encased in tiny fat particles called liposomes, which accumulate in the tumour and release slowly over time.
