Biotech Values

[DewDiligence]

Opdivo/Yervoy 1L-NSCLC sBLA—>5/15/20 PDUDA date (with priority review):

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900942.html

This is a chemo-free regimen, supported by data from the combined Part 1a and Part 1b of CHECKMATE-227, where Opdivo plus low-dose Yervoy showed statisg superior OS compared to chemotherapy alone in patients with PD-L1>=1%. (The TMB portion of the data analysis has apparently been withdrawn from consideration.)

Note: The CKECKMATE-9LA study, which tested Opdivo/Yervoy in 1L-NSCLC following two induction cycles of chemo (#msg-151836584), is not part of the above sBLA.