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Re: DewDiligence post# 943

Friday, 04/16/2021 4:32:47 PM

Friday, April 16, 2021 4:32:47 PM

Post# of 1168
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.

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