Phase 3 trial of Onivyde for small cell lung cancer misses endpoint
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Irinotecan liposomal injection as second-line treatment of small cell lung cancer failed to extend OS compared with topotecan, according to the agent’s manufacturer.
Irinotecan liposomal injection (Onivyde, Ipsen), a topoisomerase 1 inhibitor, is approved in the United States for use in combination with 5-FU and leucovorin for treatment of patients with metastatic adenocarcinoma of the pancreas whose disease progressed after gemcitabine-based therapy.
The randomized phase 3 RESILIENT trial compared the agent with IV topotecan as second-line therapy for patients with small cell lung cancer whose disease progressed on or after first-line platinum-based therapy.
Results showed no improvement in OS — the study’s primary endpoint — among patients assigned irinotecan liposomal injection, according to an Ipsen-issued press release.
Researchers reported a doubling of objective response rate — a secondary endpoint — in the irinotecan liposomal injection group. The agent’s safety profile appeared consistent with prior reports.
Complete results from the RESILIENT trial will be presented at a medical conference.
“[Although] the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, we will now work with our teams to analyze the data further before decisions regarding next steps are made,” Howard Mayer, MD, executive vice president and head of research and development at Ipsen, said in the release.
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