Ipsen, which is “not at all afraid" to challenge Big Pharma, according to CEO David Loew, is touting a win for its oncology pipeline.
In a phase 3 trial in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC), Ipsen's Onivyde—as part of a treatment regimen called Nalirifox—improved overall survival and progression-free survival compared with a standard-of-care regimen.
Specifically, the Nalirifox regimen cut the risk of death by 17% over chemotherapy. Patients on the novel treatment lived a median 11.1 months, compared with 9.2 months for the control group.
The therapy also improved progression-free survival by 1.8 months to a median of 7.4 months. That translated into a reduction in the risk of progression or death by 31% over chemo. The Onivyde-containing investigational treatment delivered an objective response rate of 41.8% compared with 36.2% for the standard-of-care therapy.
Aside from Onivyde, the Nalirifox regimen contains the chemotherapy 5-Fluorouracil, plus the colorectal cancer medication oxaliplatin, and leucovorin, which is used to manage the toxic effects of some cancer drugs.
Investigators enrolled 770 patients in 18 countries for the study. Participants in the Nalirifox group received the regimen two times a month, whereas patients in the standard-of-care group received the chemotherapies paclitaxel and gemcitabine three times a month. The company said the trial met its primary endpoint back in November.
Onivyde blocks an enzyme called topoisomerase I, which in turn helps patients' bodies copy cell DNA to make new cells. When the enzyme is blocked, cancer cells stop multiplying and eventually die, according to the company.
Ipsen plans to file a supplemental new drug application with the FDA for the treatment regimen in patients with previously untreated mPDAC following its 2020 fast-track designation. Pancreatic ductal adenocarcinoma is an "extremely aggressive" form of cancer, according to the National Institutes of Health.
Onivyde is already approved in major markets to treat patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
As for Ipsen, its CEO David Loew recently told Fierce Pharma the company is "not at all afraid" to challenge Big Pharma rivals in several disease areas. He outlined oncology, rare diseases and neuroscience as the company's areas of focus going forward, noting that gene therapy is too risky for Ipsen right now.