Study demonstrates superior PFS with Opdivo plus Yervoy

US pharma major Bristol-Myers Squibb (NYSE: BMY) this morning said that a much anticipated, late-stage trial testing its immunotherapy cancer drug Opdivo (nivolumab) in patients with a common type of lung cancer had met its main Phase III goal, sending the firm’s shares 3.99% higher to $66.01 in pre-market trading.

B-MS said the ongoing Phase III CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo plus its own drug Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high (≥10 mutations/megabase, mut/mb) tumor mutation burden (TMB), regardless of PD-L1 expression.

In the study, TMB was evaluated using Foundation Medicine’s (Nasdaq: FMI) 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 3mg/kg every two weeks and low-dose Yervoy (1mg/kg) every six weeks.