By Colin Kellaher

 

Merck & Co. on Tuesday said a Phase 3 study of its Keytruda cancer drug met the second of its dual primary endpoints as a perioperative treatment in certain patients with non-small cell lung cancer.

The Rahway, N.J., drugmaker said Keytruda in combination with chemotherapy before surgery, followed by resection and Keytruda as a single agent after surgery, showed a statistically significant and clinically meaningful improvement in overall survival in patients with resectable stage II, IIIA or IIIB non-small cell lung cancer.

A perioperative treatment regimen includes treatment before surgery and continued after surgery.

Merck in March reported that the study had met its other primary endpoint of improvement in event-free survival.

The U.S. Food and Drug Administration is currently reviewing Merck's application for expanded approval of Keytruda in the new indication, with a target action date of Oct. 16.

Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for more than 80% of all cases.

Merck is studying Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, in a raft of trials across a wide variety of cancers and treatment settings. The drug, which is approved in dozens of indications worldwide, generated sales of more than $12 billion in the first half of 2023.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

October 10, 2023 07:02 ET (11:02 GMT)

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