Replies to post #943 on Bristol Myers Squibb (BMY)

[DewDiligence]

Two new PDUFA dates for Opdivo…

5/25/21 for Opdivo/chemo in first-line gastric cancer, based on CHECKMATE-649 study:
https://www.businesswire.com/news/home/20210120005166/en

5/20/21 for Opdivo monotherapy in adjuvant esophageal or gastroesophageal junction cancer (following chemo/radiation in the neoadjuvant setting), based on CHECKMATE-577 study:
https://www.businesswire.com/news/home/20210120005097/en

Both sBLAs received an FDA priority review.

[DewDiligence]

FDA approves Opdivo/chemo for first-line gastric cancer—irrespective of PD-L1 status:

https://finance.yahoo.com/news/u-food-drug-administration-approves-171000187.html

The approval is based on the CHECKMATE-649 study, in which Opdivo/chemo showed a statsig OS benefit vs chemo alone in both the overall trial (HR=0.80; n=789) and in the PD-L1>=5% subgroup (HR=0.71; n=482). Opdivo/chemo also showed a statsig PFS benefit relative to chemo in the PD-L1 subgroup (HR=0.68).

Data from a separate CHECKMATE-648 arm testing Opdivo/Yervoy vs chemo have not been reported (AFAIK), so I presume that this arm did not show a statsig benefit in either OS or PFS.