Merck (NYSE:MRK) has halted the phase III KEYLYNK-008 study, which investigated the combination of its prominent drugs, Keytruda and Lynparza, as a potential treatment for metastatic squamous non-small cell lung cancer (NSCLC). The decision, based on the third interim analysis by an independent data monitoring committee (IDMC), revealed that the Keytruda-Lynparza combination did not demonstrate an improvement in overall survival (OS), one of the study’s primary endpoints.
Previously, the combination failed to achieve statistical significance in progression-free survival (PFS) during the second interim analysis, though a numerical improvement was noted. Merck plans to communicate the IDMC’s recommendation to study investigators and guide participants to their physicians for further treatment. Data from the KEYLYNK-008 study will be presented at a future medical meeting.
This setback follows a similar outcome for the Keytruda-Lynparza combination in the phase III KEYLYNK-010 study for metastatic castration-resistant prostate cancer (mCRPC) last year, where it failed to meet primary endpoints of OS and radiographic PFS.
Lynparza, a PARP inhibitor developed by Merck in collaboration with AstraZeneca (AZN), holds approval for ovarian, breast, prostate, and pancreatic cancers. The profit-sharing agreement between AstraZeneca and Merck, established in 2017, covers Lynparza and Koselugo.
Keytruda, an anti-PD-1 therapy, is a significant revenue driver for Merck, contributing approximately 46% to the company’s total revenues in the first nine months of 2023. With approvals for multiple cancer types, Keytruda’s sales reached $18.4 billion in the nine months ending September 2023, growing by 19% year over year. The drug’s success stems from its strong performance in metastatic indications and rapid adoption in recent earlier-stage launches, consistently expanding into new indications and global markets. Despite this setback, Merck remains a key player in the evolving landscape of cancer therapeutics.
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