Ipsen scores first-line nod for Onivyde combo in pancreatic cancer

13 Feb 2024
firstwordpharma.com
Clinical ResultPhase 3Drug ApprovalAcquisitionLicense out/in
The FDA on Tuesday approved a four-drug regimen featuring Ipsen’s Onivyde (irinotecan liposome injection) to treat first-line metastatic pancreatic adenocarcinoma. Known as NALIRIFOX, the treatment combines the topoisomerase inhibitor with fluorouracil, leucovorin and oxaliplatin.
Onivyde was previously cleared by the agency as part of a slightly different combination for metastatic pancreatic adenocarcinoma in patients who progressed following gemcitabine-based therapy.
The latest approval is welcome news for pancreatic cancer patients, who have few treatment options beyond chemotherapy. While Merck & Co.’s PD-1 inhibitor Keytruda (pembrolizumab) and its AstraZeneca-partnered PARP drug Lynparza (olaparib) are both approved for the disease, they’re limited to small, genetically defined populations. For more, see ViewPoints: Ipsen success provides epitaph for Merrimack.
NALIRIFOX’s green light was based on data from Phase III NAPOLI 3 trial, in which it bested standard care with nab-paclitaxel plus gemcitabine to improve survival for patients with metastatic pancreatic cancer.
NAPOLI 3 enrolled 770 patients who had not previously received chemotherapy. The  Onivyde regimen achieved overall survival of 11.1 months, compared with 9.2 months for the comparator arm, meeting the primary endpoint. Patients who received NALIRIFOX also had a median progression-free survival of 7.4 months, versus 5.6 months for the chemotherapy-only cohort.
Ipsen acquired US rights to OnivydeOnivyde from Merrimack Pharmaceuticals in 2017; with the first-line approval now in hand, the latter stands to receive a $225-million milestone payment.
Servier is responsible for commercialisation of OnivydeOnivyde outside of the US, as well as outside of Taiwan, where PharmaEngine has rights.
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