Bristol-Myers Squibb has had its supplemental Biologics License Application for Opdivo plus low-dose Yervoy for treating first-line advanced non-small cell lung cancer approved by the US Food and Drug Administration.
The application was based on results from Part 1 of CheckMate -227, the first and only global Phase 3 study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumour histologies and the PD-L1 expression spectrum.
CheckMate -227 is an ongoing, multi-part, open-label global Phase 3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer across squamous and non-squamous tumor histologies.
There are two co-primary endpoints in Part 1 for Opdivo plus low-dose Yervoy versus chemotherapy: overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a, which continues to final analysis) and progression-free survival (PFS) in patients with TMB ≥10 mut/Mb across the PD-L1 spectrum (assessed in patients enrolled across Parts 1a and 1b).
The primary endpoint in Part 2 is OS, and the study is ongoing.