CHECKMATE-227 is a chaotic trial (or set of trials, as BMY refers to it) that won't send a clear message about anything unless either the high-TMB subgroup (irrespective of PD-L1) or the PD-L1-positive subgroup (irrespective of TMB) shows an OS benefit for either the Opdivo/Yervoy cohort or the Opdivo/non-Yervoy cohort (which includes chemo for PD-L1-negtaive patients but not for PD-L1-positive patients).
Confusing? Yes, it is! To make matters worse, OS is neither a primary nor a co-primary endpoint in the TMB-high subgroup.
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