Irinotecan liposomal injection (Onivyde) used as second-line therapy for patients with small cell lung cancer failed to meet the primary endpoint of overall survival compared to topotecan.
The Phase 3 RESILIENT trial of irinotecan liposomal injection (Onivyde; Ipsen Biopharmaceuticals, Inc) failed to meet primary endpoint of overall survival (OS) compared to topotecan (Hycamtin; Novartis Pharmaceuticals Corporation) in patients with small cell lung cancer (SCLC), it said a press release from Ipsen. However, the secondary objective response rate endpoint increased in favor of irinotecan liposomal injection.
The randomized, open-label phase 3 study was conducted in 2 parts. The first part, read in 2020, confirmed the safety, dosage and efficacy of irinotecan liposomal injection. Part 2 of the study evaluated irinotecan liposomal injection versus topotecan in patients with SCLC who progressed on or after platinum-based first-line therapy.
In Part 2, approximately 450 patients were enrolled in a randomized trial of the efficacy of irinotecan liposomal injection versus intravenous (IV) topotecan. Researchers measured the primary outcome measure OS, as well as secondary outcomes, including progression-free survival, objective response, and quality of life.
The analysis concluded that the primary endpoint of OS was not met in patients treated with irinotecan liposomal injection versus topotecan. However, researchers observed a doubling of the secondary endpoint of objective response rates in favor of irinotecan liposomal injection.
In previous studies, the safety and tolerability of irinotecan liposomal injection was shown to be consistent with the safety profile. In addition, no new safety issues emerged during this trial.
“While the results of the RESILIENT trial analysis did not demonstrate an overall survival benefit with [irinotecan liposomal injection] in patients with second-line small cell lung cancer, we will now work with our teams to further analyze the data before making decisions about next steps,” said Howard Mayer, MD, executive vice president, Head of Research and Development at Ipsen. a statement. “These data confirm the complexity of small cell lung cancer treatment. We would like to thank the patients, their families and healthcare teams for participating in this clinical trial.”
The results of the clinical study will be communicated with a regulatory agency, and detailed results of the study 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 following disease progression following gemcitabine-based therapy. However, irinotecan liposomal injection is not indicated as monotherapy for the treatment of patients with metastatic adenocarcinoma of the pancreas.
Ipsen plans to continue exploring the potential of irinotecan liposomal injection in other areas.
Ipsen Announces Results of Phase III RESILIENT Study to Evaluate Onivyde® in Second-Line Monotherapy for Small Cell Lung Cancer [press release]. Paris, France: Business Wire; Aug 3, 2022. Accessed Aug 5, 2022. https://www.businesswire.com/news/home/20220802006066/en