Bristol-Myers announces final results from CheckMate -227 Part 1
Bristol-Myers Squibb announced results from Part 1 of the Phase 3 CheckMate -227 trial evaluating Opdivo plus low-dose Yervoy as first-line treatment for patients with advanced non-small cell lung cancer. Opdivo plus low-dose Yervoy met the independent co-primary endpoint of overall survival, demonstrating superior benefit compared to chemotherapy in patients whose tumors expressed PD-L1 greater than or equal to 1%. Additionally, in an exploratory analysis, results showed improved overall survival for patients treated with the combination of Opdivo plus low-dose Yervoy with PD-L1 less than 1%. The two-year survival rate for patients treated with the combination regimen was 40% for both patients whose tumors expressed PD-L1 greater than or equal to1% and patients whose tumors expressed PD-L1 less than1%. In the chemotherapy control arm, two-year survival rates were 33% and 23%, respectively. The safety profile of Opdivo plus low-dose Yervoy was consistent with previously reported studies in NSCLC and no new safety signals were observed. With a minimum follow-up of 29.3 months, patients treated with Opdivo plus low-dose Yervoy, regardless of PD-L1 expression level, experienced a nearly four times longer duration of response compared to patients treated with chemotherapy. In patients with PD-L1 greater than or equal to 1%, the objective response rate was 35.9% with Opdivo plus low-dose Yervoy versus 30.0% with chemotherapy. The median duration of response for the combination therapy arm was 23.2 months versus 6.2 months in the chemotherapy arm. In patients with PD-L1 less than 1%, the objective response rate was 27.3% with Opdivo plus low-dose Yervoy versus 23.1% with chemotherapy, with a median DoR of 18 months for the combination therapy arm versus 4.8 months in the chemotherapy arm.