BMY: I think the logic behind that tweet is essentially the best possible case for Opdivo + Yervoy, but the 227 data are a mess* and I have serious doubts they’ll be accepted by regulators, let alone clinicians.
*issues include extremely late protocol amendment to add TMB resulting in very low % of pts included in primary endpoint analysis, lack of OS in TMB-H, lack of benefit for Opdivo monotherapy in TMB-H, underwhelming PFS for O+Y in TMB-H, OS primary endpoint being PD-L1+ instead of TMB-H, commercial barriers to TMB testing, availability of an easier chemo-free option with Keytruda monotherapy for PD-L1 50% expressors and soon to be 1% expressors due to KEYNOTE-042.
Even if FDA approves these 227 data, I think BMY is going to have a pretty hard time convincing doctors that it’s the right regimen to use in the face of KEYNOTE-189, -024 and -042. Curious to see what the Opdivo + chemo data from 227 look like...
