El valor de la selección de pacientes en NSCLC

CheckMate-227 trial, an open-label phase 3 trial of over 2500 patients with advanced NSCLC, either squamous

or non-squamous histology, randomized to nivolumab monotherapy or in combination with ipilimumab versus

platinum doublet chemotherapy in a comparison of patients with tumors expressing PD-L1 (part 1a) or with

tumors expressing no PD-L1 (part 1b). Results for both groups on part 1, noting that there was a significant

improvement in progression-free survival (PFS) with nivolumab/ipilimumab compared to chemotherapy in the

subset of patients with high tumor mutation burden (TMB) defined as

>10 mutations/megabase (

mut/MB) on

the FoundationOne CDx assay (40-45% of patients) and

TMB as >20 mut/MB

(13%),

independently of PD-L1

CheckMate 227 combined

nivolumab and ipilimumab 1L

therapy in NSCLC