Biotech Values

[DewDiligence]

BMY -3%/AH on mixed outcome for Yervoy/Opdivo combo in RCC:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-topline-203000992.html

Bristol-Myers Squibb Company announced topline results today from the CheckMate-214 trial investigating Opdivo…in combination with Yervoy…versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma.

The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. Median duration of response was not reached for the combination of Opdivo and Yervoy and was 18.17 months for sunitinib.

While there was an improvement in progression-free survival (PFS) (HR=0.82, [95% CI 0.64 – 1.05]; stratified 2-sided p=0.03), it did not reach statistical significance. The median PFS was 11.56 months (95% CI 8.71 – 15.51) for the Opdivo and Yervoy combination versus 8.38 months (95% CI 7.03-10.81) for sunitinib.

The study will continue as planned to allow the third co-primary endpoint of overall survival to mature.

I-O trials have a mixed record of hitting on OS after missing on PFS, so this trial could yet show a statsig survival benefit. On the other hand, the PFS miss is likely to reinforce the drumbeat that adding Yervoy to Opdivo doesn’t accomplish much (except in first-line melanoma).