Replies to post #214921 on Biotech Values

[ghmm]

BMY / CTMX:

Don't know if this is news but apparently there is a second CTLA-4 program in the collaboration

http://ir.cytomx.com/phoenix.zhtml?c=254195&p=irol-newsArticle&ID=2315188

Bristol-Myers Squibb (BMS) Partnership

. BMS continues to advance its CTLA-4-directed Probody therapeutic, which is expected to enter the clinic in early 2018.
. In addition, CytomX and Bristol-Myers Squibb are evaluating a Probody version of Bristol-Myers Squibb's CTLA-4 nonfucosylated (CLTA-4-NF) version of ipilimumab as part of the current collaboration.

Had to google nonfucosylated never heard that before!

[DewDiligence]

BMY—PDUFA date for Opdivo/Yervoy in first-line RCC is 4/16/18 (with priority review):

https://www.businesswire.com/news/home/20171213006196/en

The sBLA is based on the CHECKPOINT-214 study (#msg-136010123).

[DewDiligence]

FDA approves Opdivo/Yervoy combo in first-line RCC:

https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-yerv?linkId=50524011

Today was the PDUFA date. The approval is based on the CHECKPOINT-214 study (#msg-136010123).

This approval was fully expected, and hence it’s doing nothing to arrest today’s sell-off.

[DewDiligence]

BMY—CHMP approves Opdivo-plus-low-dose-Yervoy in first-line RCC, regardless of PD-L1 status:

https://www.businesswire.com/news/home/20181115005934/en/Bristol-Myers-Squibb-Receives-Positive-CHMP-Opinion-Recommending

Formal approval the EC Commission will follow in 2-3 months.

The CHMP decision is based on the CHECKMATE-214 study, in which the OS HR in the overall trial was 0.63 for Opdivo/Yervoy vs Sutent (#msg-136010123). The OS HR was 0.73 in PD-L1-negative patients and was 0.45 in PD-L1-positive patients.

p.s. CHECKMATE-214 has nothing whatsoever to do with NKTR-214!