Merck Moves Ahead With Late-Stage Trial Win

Health and Healthcare

Published: April 9, 2018 10:05 am

Last Updated: January 12, 2020 1:38 am

Shares of Merck & Co. Inc. (NYSE: MRK) had a boost early Monday after the firm announced that its Phase 3 trial of Keytruda for the treatment of metastatic non-small cell lung cancer (NSCLC) met its primary endpoint for overall survival.

An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with Keytruda resulted in significantly longer overall survival than platinum-based chemotherapy in patients with a PD-L1 tumor proportion score (TPS) of at least 1%. As part of a prespecified analysis plan, overall survival was sequentially tested and was significantly improved in patients with a TPS of at least 50%, with a TPS of at least 20% and then in the entire study population with a TPS of at least 1%.

The safety profile of Keytruda in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.

Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival, which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.

Dr. Roger M. Perlmutter, president of Merck Research Laboratories, commented:

With KEYNOTE-042, KEYTRUDA has now shown a significant survival benefit compared with chemotherapy for patients with locally advanced or metastatic nonsquamous or squamous NSCLC expressing PD-L1 at 1 percent or higher by tumor proportion score. KEYTRUDA is a foundational treatment for NSCLC and has consistently demonstrated a survival benefit as monotherapy, or in combination with chemotherapy, in the treatment of metastatic lung cancer. We sincerely thank the patients and clinical investigators for their participation in this important study.

Shares of Merck traded up 2.8% to $54.86 Monday morning, with a consensus analyst price target of $66.55 and a 52-week range of $52.90 to $66.41.