Onivyde Fails to Improve Survival Over Chemotherapy in Second-Line Small Cell Lung Cancer

Treatment with Onivyde (irinotecan liposomal injection) failed to improve overall survival when compared with the chemotherapy topotecan in patients with small cell lung cancer whose disease failed to respond to platinum-based first-line treatment, according to an update from Onivyde’s manufacturer, Ipsen.

The notice from Onivyde’s manufacturer is a result of its phase 3 RESILIENT trial failing to meet its main goal of showing an overall survival benefit with Onivyde over the chemotherapy topotecan. Overall survival, according to the National Cancer Institute, is a measure of time from the date of cancer diagnosis or the start of treatment to death from any cause.

“While 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,” Dr. Howard Mayer, the executive vice president and head of research and development at Ipsen, said in a press release. “These data confirm the complexities associated with treating small cell lung cancer.”

In 2020, Ipsen released information from the first part of the phase 3 RESILIENT trial which determined that treatment with single-agent Onivyde every two weeks was safe and well tolerated.

As a result, the manufacturer continued to the second part of the trial which randomized patients with small cell lung cancer whose disease failed to respond to platinum-based first-line treatment to receive either Onivyde or topotecan delivered intravenously.

Approximately 450 patients across more than 100 cancer centers around the world were enrolled onto the second portion of the trial.

Aside from evaluating overall survival benefit, the investigators also analyzed progression-free survival (time during and after treatment a patient lives without disease progression) and objective response (percentage of patients whose disease partially or completely responds to treatment) rates.

Although Onivyde failed to meet the main goal of improving overall survival versus topotecan, the findings showed that treatment with study drug was associated with a doubling of objective response rate compared with the chemotherapy.

Onivyde is approved for use in combination with chemotherapy for patients with metastatic pancreatic cancer and also has been shown to improve outcomes in patients with metastatic liver cancer.

Ipsen noted that it will distribute the findings of the phase 3 RESILIENT trial to regulatory agencies and that detailed results will be presented at an upcoming medical conference.

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