Merck: Phase 3 Keytruda Study Meets One of Dual Primary Endpoints
March 02 2020 - 7:23AM
Dow Jones News
By Colin Kellaher
Merck & Co. on Monday said a phase 3 study evaluating its
cancer drug Keytruda in adults with relapsed or refractory
classical Hodgkin lymphoma met one of its dual primary
endpoints.
The Kenilworth, N.J., drug maker said Keytruda showed a
statistically significant and clinically meaningful improvement in
progression-free survival compared with the currently approved
therapy of brentuximab vedotin.
Merck said the other primary endpoint of overall survival wasn't
formally tested at this interim analysis per the study's
pre-specified analysis plan.
Merck said Keytruda's safety profile was consistent with
previous studies, with no new safety signals identified.
The U.S. Food and Drug Administration in March 2017 approved
Keytruda for adults and pediatric patients with refractory
classical Hodgkin lymphoma, or who have relapsed after three or
more prior lines of therapy. The company said the latest study data
are strongly supportive of Keytruda's current indication.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 02, 2020 07:08 ET (12:08 GMT)
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