Biotech Values

[DewDiligence]

Keytruda monotherapy showed statsig-better OS than chemo in KEYNOTE-042 study for patients with PD-L1≥1% (i.e. the entire study population) at an interim analysis:

https://finance.yahoo.com/news/keytruda-pembrolizumab-monotherapy-met-primary-104500942.html

The Keytruda HR for OS has not yet been disclosed; it will be presented at a future medical conference.

Keytruda monotherapy for patients in first-line NSCLC with PD-L1≥50% was approved by the FDA in Oct 2016 (#msg-126020834) and by the CHMP in Dec 2016 (#msg-127266701); this cutoff will now presumably be lowered to 1% based on the results reported today.

Note: MRK’s KEYNOTE-042 study had almost the same patient population as BMY’s CHECKPOINT-026 study, which failed to show superiority to chemo in Aug 2016 (#msg-124331983); the minor difference between the two is that the PD-L1 cutoff in CHECKPOIN-026 was 5% rather than 1%.