Multinational phase 2 trial of biomarker-directed pembrolizumab-based combination therapy for non-small cell lung cancer

Although pembrolizumab confers clinical benefit in non-small cell lung cancer (NSCLC), only a subset of patients will respond due to a heterogeneous tumor microenvironment. The multinational phase 2 KEYNOTE-495/KeyImPaCT trial evaluated pembrolizumab-based combination therapies for biomarker-based subgroups of patients with previously untreated advanced NSCLC. The primary outcome was investigator-assessed objective response rate. The ORR with pembrolizumab plus lenvatinib in the group with Tcell_infGEP^non-lowTMB^non-high tumors met the pre-specified efficacy threshold.