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DewDiligence

11/22/19 11:29 AM

#227036 RE: DewDiligence #225356

Tecentriq/Avastin shows superior OS—(HR=0.58)—and superior PFS—(HR-0.59)—compared to Nexavar monotherapy in first-line HCC:

https://www.businesswire.com/news/home/20191122005376/en

Checkpoint inhibitors alone have previously shown only modest (non-statsig) efficacy in HCC—e.g. #msg-149555601, #msg-146956118.

It’s somewhat bizarre to see Avastin playing a role in a new indication after all these years.
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DewDiligence

03/11/20 10:45 AM

#229129 RE: DewDiligence #225356

FDA approves Opdivo/Yervoy in second-line HCC (following Nexavar in the first line):

https://www.businesswire.com/news/home/20200311005141/en

This is an accelerated approval based on ORR and DoR in the CHECKMATE-40 study—the same study that led to FDA accelerated approval of Opdivo monotherapy in second-line HCC in Sep 2017 (https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-receives-fda-approval-t ).

p.s. In first-line HCC, Opdivo monotherapy failed to best Nexavar in the CHECKMATE-459 study (#msg-149555601).