Phase 3 Trial Investigating Onivyde for Small Cell Lung Cancer Fails to Meet Primary End Point


Irinotecan liposomal injection (Onivyde) used as second-line therapy for patients with small cell lung cancer did not meet the primary end point of overall survival compared to topotecan.

The phase 3 RESILIENT trial investigating irinotecan liposomal injection (Onivyde; Ipsen Biopharmaceuticals, Inc) did not meet its primary end point of overall survival (OS) compared to topotecan (Hycamtin; Novartis Pharmaceuticals Corporation) in patients with small cell lung cancer (SCLC), according to a press release from Ipsen. However, the secondary end point of objective response rate increased in favor of irinotecan liposomal injection.

The randomized, open-label phase 3 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 of the trial 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 (IV) 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, researchers observed 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. Additionally, no new safety concerns emerged during this trial.

“While the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with [irinotecan liposomal injection] 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,” said Howard Mayer, MD, executive vice president, Head of Research and Development at Ipsen, in a statement. “These data confirm the complexities associated with treating small cell lung cancer. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial.”

The clinical study results will be communicated with a regulatory agency, and detailed results from the trial will be presented at an upcoming medical conference.

In most major markets, including the United States, Europe, and Asia, irinotecan liposomal injection is approved for use in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. However, irinotecan liposomal injection is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

Ipsen plans to continue to explore the potential of irinotecan liposomal injection in other areas.


Ipsen announces results from Phase III RESILIENT trial evaluating Onivyde® in second-line monotherapy for small cell lung cancer [press release]. Paris, France: Business Wire; August 3, 2022. Accessed August 5, 2022.

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