Phase III RESILIENT trial of Onivyde fails to meet primary endpoint in small cell lung cancer

The secondary end point of objective response rate increased in favor of irinotecan liposomal injection. The randomized, open-label phase III trial was conducted in 2 parts. The first part, which was read out in 2020, confirmed the safety, dosing, and efficacy of irinotecan liposomal injection. Part 2 evaluated irinotecan liposomal injection versus topotecan in patients with SCLC who have progressed on or after platinum-based first-line therapy.

In Part 2 approximately 450 patients were enrolled in a randomized efficacy study of irinotecan liposomal injection versus intravenous topotecan. Researchers measured the primary outcome OS, as well as secondary outcomes including progression-free survival, objective response rate, and quality of life. The analysis concluded that the primary end point OS was not met in patients treated with irinotecan liposomal injection versus topotecan. However, there was a doubling of the secondary end point of objective response rate in favor of irinotecan liposomal injection. The safety and tolerability of irinotecan liposomal injection was found to be consistent with its safety profile in previous studies. Finally no new safety concerns emerged during this trial. The results of the clinical study will be communicated with a regulatory agency and detailed results from the trial will be presented at an upcoming medical conference.