Replies to post #205419 on Biotech Values

[Titan V]

More 'halo effect' for Keytruda? Merck asks NCCN for chemo-combo backing in lung cancer
http://www.fiercepharma.com/marketing/more-halo-effect-for-keytruda-merck-asks-nccn-for-chemo-combo-backing-lung-cancer

[DewDiligence]

Re: Keytruda duration of Tx in 1L-NSCLC

Follow-up to the bottom paragraph of #msg-126020834:

$MRK For 3rd-party payers,worst place 2pick fight is cutting off Tx that's working in life-thrtng indictn,where duration in label=arbitrary. https://t.co/T5AqGjWpL5

— Roy Friedman (@DewDiligence) October 25, 2016

[DewDiligence]

CHMP approves MRK’s Keytruda in first-line NSCLC with high PD-L1 expression:

http://finance.yahoo.com/news/european-medicines-agency-chmp-recommends-122600542.html

The FDA approved Keytruda in this indication in Oct 2016 (#msg-126020834).

[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%.