Replies to post #218510 on Biotech Values

[DewDiligence]

Re: Keytruda in adjuvant melanoma

Apparently, this is a disease setting where PD-L1 expression doesn’t matter as much as it usually does. In the excerpt you posted, the HR for RFS* was 0.67 for the entire trial and 0.64 (a little better) for the PD-L1-positive subgroup.

*a/k/a DFS; equivalent to PFS in settings where all patients begin the trial with no observed disease.

[DewDiligence]

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.