Phase III CheckMate-227 study of nivolumab + ipilimumab combo in NSCLC meets co-primary endpoint

CheckMate-227, an open-label, phase III trial with more than 2,500 patients, meets its co-primary endpoint of progression-free survival (PFS) with nivolumab (Opdivo, Bristol-Myers Squibb [BMS]) plus ipilimumab (Yervoy, BMS) combination vs chemotherapy in first-line, advanced, non-small cell lung cancer (NSCLC) patients whose tumors have high (≥10 mutations/megabase) tumor mutation burden (TMB), regardless of programmed death-ligand 1 expression. TMB is evaluated using analytically validated assay FoundationOne CDx. On the basis of an interim analysis for overall survival, the data monitoring committee recommended that the study continue. The safety profile was consistent with previously reported findings in first-line NSCLC for this combination.

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