Bristol Myers Squibb (BMY)

[DewDiligence]

FDA approves Opdivo/Yervoy in 1L-NSCLC following two cycles of standard chemotherapy irrespective of PD-L1 expression:

https://investors.bms.com/iframes/press-releases/press-release-details/2020/US-Food-and-Drug-Administration-Approves-Opdivo-nivolumab--Yervoy-ipilimumab-Combined-with-Limited-Chemotherapy-as-First-Line-Treatment-of-Metastatic-or-Recurrent-Non-Small-Cell-Lung-Cancer/default.aspx

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.