Merck: Phase 3 Keytruda Study Hits Second Goal in Non-Small Cell Lung Cancer
10 Octobre 2023 - 1:17PM
Dow Jones News
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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