The Phase III trial shows that PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved OS compared with chemotherapy alone with locally advanced NSCLC.
nitpicker/Shutterstock
Findings from the Phase III EMPOWER-Lung 3 trial, announced today by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival (OS) compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
The study was stopped early after it met its primary endpoint of OS. According to a statement published Thursday by Regeneron Pharmaceuticals and Sanofi, the data from the trial are expected to provide the basis of U.S. and European Union regulatory submissions for Libtayo. Back in June, the European Commission approved Libtayo for first-line management of NSCLC and metastatic or locally advanced basal cell carcinoma.
Lung cancer represents the leading cause of mortality across the globe. Approximately 2.2 million new lung cancer cases were reported in 2020, which included 225,000 new cases of the disease in the U.S. Around 84% of lung cancer cases of NSCLC, with three-fourths of these cases diagnosed in later stages of the disease.
The use of PD-1 inhibitors alone has advanced the NSCLC treatment landscape for disease with ≥50% PD-L1 expression. Still, up to 70% of all cases of feature <50% PD-L1 expression.
In the EMPOWER-Lung 3 trial, the combination of Libtayo and chemotherapy was associated with an increase in median OS to 22 months in patients with advanced NSCLC and tumors with either squamous or non-squamous histology across all PD-L1 expression levels. In contrast, patients in the chemotherapy alone group experienced a median survival of only 13 months.
“Notably, the Phase III trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease,” said study investigator Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center in Tbilisi, Georgia. “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.”
During a protocol-specified interim analysis, the study’s Independent Data Monitoring Committee (IDMC) recommended stopping the study early, given the survival findings. The top-line initial investigation, which included a total of 466 patients, found the Libtayo and chemotherapy combo was associated with a 29% reduction in the risk of death compared with chemotherapy alone (hazard ratio, 0.71; 95% CI, 0.53-0.93; p=0.014).
Additionally, the IDMC analysis found no new Libtayo safety signals. Regeneron and Sanofi said further efficacy and safety data will be presented at an upcoming medical conference.
Interm analysis findings from the Phase III EMPOWER-Lung 3 trial were announced simultaneously with Regeneron’s second quarter 2021 financial and operating results. In the report, Regeneron said it saw its Q2 2021 revenues increase 163% to $5.14 billion compared with its year-on-year results. The company also announced in the report that its therapy Dupixent (dupilumab), also jointly developed with Sanofi, significantly improved itch and hives in a study of patients with chronic spontaneous urticaria, paving the way for approval of the treatment in this indication.
Featured Jobs on BioSpace
