Libtayo Phase III Trial stopped early due to significant improvement in overall survival
pharmafile | August 6, 2021 | News story | Medical Communications |
The Phase III trial of Sanofi and Regeneron’s PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy was stopped early due to significant improvement in overall survival (OS) in patients with first-line advanced non-small cell lung cancer.
Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels.
Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death.
Miranda Gogishvili, an Oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a Trial Investigator, said: “Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone.
“Notably, the Phase III trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease.
“These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression.”
The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis.
Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively.
Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages.