Bristol Myers Squibb (BMY)

[DewDiligence]

FDA approves Opdivo/chemo in neoadjuvant* NSCLC, irrespective of PD-L1 status:

https://www.businesswire.com/news/home/20220301006264/en

This is a large potential market and Opdivo is the only FDA-approved immunotherapy in the NSCLC neoadjuvant setting (i.e. before surgical resection).

The approval is based on the CHECKMATE-816 study, where Opdivo/chemo bested chemo alone with the HR for EFS=0.63. Additionally, 24% of patients in the Opdivo/chemo arm had a pathological complete response (no detectable cancer) vs 2% in the chemo-only arm.

OS, which was not a primary endpoint in this trial, had an impressive HR=0.57; however, so little alpha was allocated to OS in the statistical analysis plan that the HR=0.57 result was not deemed statsig.

*Stage Ib, II, or IIIa.