Merck’s Keytruda Grabs Another Late-Stage Clinical Win in Lung Cancer

Merck & Co. is chalking up another clinical win for its potent checkpoint inhibitor Keytruda. This morning the company announced the anti-PD-1 therapy hit its endpoints as a first-line monotherapy in lung cancer following an interim review of data.

An Independent Data Monitoring committee said the interim analysis showed Keytruda met its key endpoint of overall survival in the Phase III KEYNOTE-042 trial testing the checkpoint inhibitor as a monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), which includes including nonsquamous or squamous histologies. Treatment with Keytruda, according to the Independent Data Monitoring Committee, resulted in significantly longer overall survival than platinum-based chemotherapy in patients who have a PD-L1 tumor proportion score (TPS) of equal to or greater than 1 percent.

Merck said part of the pre-specified analysis plan in the Phase III trial was a sequential testing of overall survival the late-stage trial included 1,274 patients.

Roger Prelmuter, president of Merck Research Laboratories, said 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."

As part of a pre-specified analysis plan, overall survival was sequentially tested and was significantly improved in patients with a TPS of equal to or greater than 50 percent. Overall survival was also improved in patients with a TPS of equal to or greater than 20 percent. It was also shown in the entire study population with a TPS of equal to or greater than 1 percent, Merck added.  

"Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomized Phase III study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher," Tony Mok, a professor in the Department of Clinical Oncology at the Chinese University of Hong Kong, S.A.R., China, said in a statement.

NSCLC is the most common type of lung cancer. It accounts for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the United States with any stage of lung cancer is estimated to be 18 percent, according to data shared by Merck. If Merck is able to secure approval for Keytruda for this lung cancer indication it will open up a larger market share for the company. Sales of Keytruda generated more than $3.8 billion for Merck in 2017.

Although the Independent Data Monitoring Committee determined that Keytruda hit its primary endpoint in the Phase III trial, Merck said the study will continue in order to evaluate the secondary endpoint of progression-free survival.

Keytruda has been approved by the U.S. Food and Drug Administration for multiple cancer indications, including melanoma, head and neck cancer and several types of lung cancer.

Shares of Merck are up 2.7 percent in premarket trading to $54.80.

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