In comparison to a standard-of-care regimen, Ipsen’s Onivyde—a component of the Nalirifox therapy regimen—improved overall survival and progression-free survival in a phase 3 study in previously untreated metastatic pancreatic ductal adenocarcinoma.
Onivyde is a long-circulating liposomal topoisomerase inhibitor that was evaluated in the Phase 3 NAPOLI study for patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
The participants had not previously received treatment for the condition. The findings, which were presented during the abstract session presentation, concentrated on enhanced overall survival and progression-free survival in comparison with nab-paclitaxel plus gemcitabine.
Particularly, compared to chemotherapy, the Nalirifox regimen reduced the chance of death by 17%. Patients receiving the new therapy had a median life expectancy of 11.1 months as compared to 9.2 months for the control group.
Additionally, the treatment increased median progression-free survival by 1.8 months to 7.4 months. This resulted in a 31% decrease in the probability of death or progression compared to treatment. In comparison to the standard medication, which had an objective response rate of 36.2%, the experimental treatment that contained Onivyde had a 41.8% rate.
In addition to Onivyde, the Nalirifox regimen also includes the chemotherapy medicine Fluorouracil, the colorectal cancer treatment oxaliplatin, and the anti-toxin leucovorin.
For the study, researchers shortlisted 770 individuals from 18 different nations. Patients in the standard-of-care group received paclitaxel and gemcitabine three times a month, whereas, those in the Nalirifox group received the regimen twice a month. At the end of 2022, the company said that the trial’s main target has been achieved.
Howard Mayer EVP at 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. 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.”
Topoisomerase I is one of the enzymes that is blocked by Onivyde, allowing patients’ bodies to replicate cell DNA while creating new cells. According to the company, cancer cells stop growing and finally perish when the enzyme is stopped.
Following its 2020 fast-track designation, Ipsen intends to submit an additional new drug application request to the FDA for the treatment regimen in patients with previously untreated diseases.
The National Institutes of Health describe pancreatic ductal adenocarcinoma as an aggressive kind of cancer.
Major markets have already authorized the use of Onivyde to treat patients with metastatic pancreatic adenocarcinoma that has progressed after receiving gemcitabine-based treatment.
The CEO of Ipsen, David Loew outlined oncology, rare diseases, and neuroscience as the company’s areas of focus going forward, while explaining that gene therapy is too risky for Ipsen right now.