Phase III CHECKMATE-227 study of Opdivo + Yervoy meets primary endpoint in first line NSCLC in patients with tumor mutation burden .- BMS.

Bristol-Myers Squibb Company announced that the ongoing Phase III CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high ( more than or equal to 10 mutations/megabase, mut/mb) tumor mutation burden (TMB), regardless of PD-L1 expression.

In the study, TMB was evaluated using Foundation Medicine�s analytically validated assay FoundationOne CDx. Additionally, based on an interim analysis for overall survival (OS), the Data Monitoring Committee recommended that the study continue. The safety profile was consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks.

About Tumor Mutation Burden (TMB): Over time, cancer cells accumulate mutations that are not seen in normal cells of the body. Tumor mutation burden, or TMB, is a quantitative biomarker that reflects the total number of mutations carried by tumor cells. Tumor cells with high TMB have higher levels of neoantigens, which are thought to help the immune system recognize tumors and incite an increase in cancer-fighting T cells and an anti-tumor response. TMB is one type of biomarker that may help predict the likelihood a patient responds to immunotherapies.