Bristol Myers Squibb announced three-year follow-up results from Part 1 of the Phase III CheckMate -227 trial , demonstrating that Opdivo (nivolumab) plus Yervoy (ipilimumab) provided sustained improvements in overall survival (OS) and additional efficacy measures as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
With a median follow-up of more than three years (43.1 months), Opdivo plus Yervoy continued to show a survival benefit compared to chemotherapy [Hazard Ratio (HR): 0.79; 95% Confidence Interval (CI): 0.67 to 0.93] among patients whose tumors expressed PD-L1
greater than 1%. Three-year OS rates in this population were 33% for Opdivo plus Yervoy, compared to 22% for chemotherapy alone. Opdivo plus Yervoy also delayed disease progression or death among these patients, with a three-year progression-free survival (PFS) rate of 18% with the combination versus 4% with chemotherapy alone.
Thirty-eight percent of patients with PD-L1 greater then 1% who responded to Opdivo plus Yervoy remained in response three years after the onset of the response versus 4% for chemotherapy alone. These ongoing responses were observed in the absence of treatment with Opdivo plus Yervoy, which were given for a maximum of two years per the trial protocol.
In an exploratory landmark analysis of OS by response status, 70% of patients whose tumors expressed PD-L1 greater than 1% and who had a complete or partial response by six months to the Opdivo plus Yervoy combination were alive three years later, compared to 39% of patients treated with chemotherapy. In an exploratory analysis of patients whose tumors expressed PD-L1 less than 1%, Opdivo plus Yervoy demonstrated three-year OS rates of 34%, compared to 15% for chemotherapy alone (HR: 0.64; 95% CI: 0.51 to 0.81). Additionally, 13% versus 2% of patients remained alive and progression-free from time of randomization; and 34% versus 0% of patients with confirmed responses to treatment remained in response three years after the onset of the response, respectively.
The safety profile of Opdivo plus Yervoy was consistent with previously reported studies in NSCLC, and no new safety signals were observed. These results (Abstract #9500) will be featured in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting 2020, held virtually, from May 29-31.
The addition of Yervoy to Opdivo also continued to show benefit compared to Opdivo monotherapy in patients whose tumors expressed PD-L1 greater than 1% and compared to Opdivo plus chemotherapy in those with PD-L1 less than 1% with a minimum of three years of follow-up.