French pharmaceutical company Ipsen SA (IPSEY) announced Wednesday that the Phase III RESILIENT trial evaluating Onivyde did not meet its primary endpoint of overall survival compared to topotecan in second-line monotherapy for small cell lung cancer.
The trial is evaluating Onivyde (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer or SCLC, who have progressed on or after platinum-based first-line therapy treatment.
RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan.
The company plans to present the detailed results from the RESILIENT trial at an upcoming medical conference.
Ipsen said the analysis concluded that the primary endpoint overall survival was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate or ORR in favor of Onivyde was observed.
The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged.
Ipsen said the clinical study results will be communicated with the regulatory agency.
Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Ipsen will continue to explore the potential of Onivyde in other areas, and the final data readout of the NAPOLI-3 Phase III trial in first-line pancreatic ductal adenocarcinoma is expected in H2 2022.
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