Merck (NYSE:MRK) announced that its phase III KEYLYNK-006 study, which evaluated the combination of Keytruda and Lynparza in certain non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoints.
The study assessed Keytruda, in combination with Lynparza as maintenance therapy, as a first-line treatment for patients with metastatic non-squamous NSCLC without EGFR, ALK, or ROS1 genomic tumor aberrations. The control group received pemetrexed chemotherapy instead of Lynparza.
The combination treatment did not meet the study’s pre-specified statistical criteria for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to those who received the Keytruda-pemetrexed combo.
This is not the first setback for the Keytruda-Lynparza combination in NSCLC. In December, Merck reported results from the phase III KEYLYNK-008 study, which evaluated the combination as a first-line treatment for patients with metastatic squamous NSCLC. This study also failed to show an improvement in OS, one of the study’s dual primary endpoints, and previously failed to achieve the other dual primary endpoint of PFS during the second interim data analysis.
A full evaluation of the data from the KEYLYNK-006 study is ongoing, and management plans to share the results with the scientific community.
Merck’s stock has gained 13.4% year-to-date compared to the industry’s 13.2% growth.
The Keytruda-Lynparza combination also faced a setback in prostate cancer indication. In 2022, Merck halted the phase III KEYLYNK-010 study evaluating the combination in patients with metastatic castration-resistant prostate cancer (mCRPC) due to the failure to achieve its primary endpoints of OS and radiographic PFS.
Lynparza, a PARP inhibitor, was developed by Merck in collaboration with AstraZeneca. Lynparza is approved for ovarian, breast, prostate, and pancreatic cancers.
Keytruda, an anti-PD-1 therapy, is a major revenue driver for Merck, contributing around 42% to its total revenues in 2023. The drug is approved for several cancer types and continues to grow and expand into new indications and markets globally. Merck recorded $25.0 billion in Keytruda sales in 2023, up 19% year-over-year, driven by strong momentum in metastatic indications and rapid uptake in recent earlier-stage launches.
Featured Image: Megapixl
Author Stephanie Bédard-Châteauneuf