Landmark five-year data from phase III CheckMate -227 trial demonstrates long-term, durable survival outcomes with Opdivo + Yervoy in first-line treatment of patients with metastatic non-small cell lung cancer.

With a minimum follow-up of over five years (61.3 months), the longest reported for an immunotherapy combination in mNSCLC: i.In the primary endpoint population of patients with tumor PD-L1 expression greater than 1%, the five-year survival rate for Opdivo plus Yervoy was 24%, compared to 14% for chemotherapy (Hazard Ratio [HR] 0.77; 95% Confidence Interval [CI]: 0.66 to 0.91). ii. In an exploratory analysis of patients with PD-L1 expression less than 1%, almost three times as many patients treated with Opdivo plus Yervoy were alive at five years compared to those treated with chemotherapy (19% vs. 7%, respectively; HR 0.65; 95% CI: 0.52 to 0.81). iii. Among those who responded to treatment, more patients who received Opdivo plus Yervoy remained in response vs. chemotherapy at five years (after being off treatment for more than three years, which ended at a maximum of two years for immunotherapy according to the trial protocol) in both the PD-L1 greater than 1% (28% vs. 3%, respectively) and less than 1% (21% vs. 0%, respectively) subgroups. iv. Among patients treated with Opdivo plus Yervoy who were alive at five years, approximately two-thirds (66% of patients with PD-L1 expression greater than 1% and 64% of patients with PD-L1 expression less than 1%) did not receive any subsequent therapy for more than three years after stopping treatment.

The safety profile for the dual immunotherapy combination remained consistent with previously reported data from this trial and was manageable with established protocols, with no new safety signals identified.

These data will be featured in a late-breaking poster presentation (Abstract #LBA9025) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 6, 2022, from 9:00 a.m. to 12:00 p.m. EDT.