Additional Relevant Details
Additional data from CheckMate -227 presented at AACR 2018 include subgroup analyses by tumor PD-L1 expression in patients with TMB ≥10 mut/Mb. In these analyses, PFS was significantly improved with the combination versus chemotherapy in patients with PD-L1 ≥1% (HR 0.62; 95% CI: 0.44 to 0.88) and PD-L1 <1% (HR 0.48; 95% CI: 0.27 to 0.85). Increased benefit with Opdivo plus low-dose Yervoyversus chemotherapy was also observed in patients with squamous histology (HR 0.63; 95% CI: 0.39 to 1.04) and non-squamous histology (HR 0.55; 95% CI: 0.38 to 0.80).In the study, PFS also was evaluated with Opdivo versus chemotherapy among patients with TMB ≥13 mut/Mb and ≥1% PD-L1 expression as a secondary endpoint. An improvement in PFS with Opdivo monotherapy was not observed (HR 0.95; 97.5% CI: 0.61 to 1.48; p=0.7776).