This approval is based on the CHECKMATE-9LA study, which I’ve argued is more commercially consequential than BMY’s Opdivo/Yervoy approval in 1L-NSCLC based on CHECKMATE-227 (#msg-155664766).
The premise of CHECKMATE-9LA—using induction chemotherapy to arrest rapid disease progression and thereby procure more time for the dual I-O agents to work, without subjecting patients to the simultaneous toxicity of dual I-O agents and chemo—was borne out by the results. The induction-chemo-followed-by-Opdivo/Yervoy arm showed statsig better OS than the chemo-only arm, with HR=0.69; (p=0.0006).
The dosing in the newly approved indication is: Opdivo 360mg q3w and Yervoy 1mg/kg q6w. This FDA approval came more than two months before the 8/6/20 PDUFA date.
$BMY's CHECKMATE-9LA (unlike CM-227) was a well-structured trial. It had a clear premise: using induction chemo to arrest rapid disease progression w/o subjecting patients to simultaneous toxicity of dual I-O agents *and* chemotherapy. Mission accomplished.
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