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.
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.