Bristol Myers Squibb (BMY)

[DewDiligence]

Opdivo/chemo shows statsig-superior pCR compared to chemo alone in neoadjuvant NSCLC (a large addressable market):

https://finance.yahoo.com/news/opdivo-nivolumab-plus-chemotherapy-shows-105900941.html

Bristol Myers Squibb today announced that the Phase 3 CheckMate-816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone.

CheckMate-816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

The neoadjuvant setting is where a drug is given prior to surgical resection with curative intent.

The hazard ratio for pCR has not been publically disclosed. CHECKMATE-816 remains blinded to the other primary endpoint of EFS (Event-Free Survival, which is essentially the same as DFS and PFS).

All told, the above is a pretty big deal for BMY’s Opdivo franchise.