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Ann: 2021 EGM Presentation, page-13

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  1. 601 Posts.
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    It appears the PD-(L)1 honeymoon is finally over.
    Incyte revealed late Friday the FDA has slammed its PD-1 retifanlimab — which was under priority review for locally advanced or metastatic squamous cell carcinoma of the anal canal — with a complete response letter, demanding “additional data” to show clinical benefit.
    it also signals an official shift in the agency’s handling of checkpoint blockers, if not cancer drugs in general: Five years after the landmark first approval for Merck’s Keytruda, and with eight PD-(L)1 drugs on the market, there will be no more easy passes.

    And the honeymoon period for LAG-3 and 'efti' is just beginning....in multiple combination settings, including approved PD-1 drug makers who will likely need a USP (unique selling proposition) to maintain or increase their market share.....
 
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