Biotech Values

[DewDiligence]

BMY—CHECKMATE-9LA BLA—>8/6/20 PDUFA—(with FDA priority review):

https://www.businesswire.com/news/home/20200408005057/en

CHECKMATE-9LA compared Opdivo + low-dose Yervoy following two cycles of induction chemotherapy (i.e. patients never received I-O agents and chemo at the same time) to standard chemotherapy (up to four cycles) in first-line NSCLC regardless of PD-L1 expression. The trial met its OS primary endpoint at an interim analysis in Oct 2019 (#msg-151836584) and was a major comeback for BMY in first-line NSCLC after having botched the CHECKMATE-227 study.

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.