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DewDiligence

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DewDiligence

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Re: jbog post# 218510

Monday, 06/25/2018 11:51:35 AM

Monday, June 25, 2018 11:51:35 AM

Post# of 251799
MRK—Keytruda-monotherapy PDUFA in adjuvant melanoma is 2/16/19 (with standard review):

https://www.businesswire.com/news/home/20180625005496/en

This sBLA is based on the KEYNOTE-054 study (#msg-140054359, where the HR for DFS (primary endpoint) was an impressive 0.57 in the overall study.

For PD-L1-positive patients in KEYNOTE-054, the HR for DFS was 0.54—only slightly better than the HR for the overall study. IOW, adjuvant melanoma appears to be an indication where PD-L1 status may not matter much.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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