Bristol Myers Squibb announced the first presentation of results from the Phase III CheckMate -9LA trial, which demonstrated a statistically significant and clinically meaningful survival benefit with Opdivo (nivolumab) plus Yervoy (ipilimumab), given concomitantly with two cycles of chemotherapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC)
The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) for the dual immunotherapy plus chemotherapy combination versus chemotherapy alone. At a prespecified interim analysis for the primary endpoint of OS . Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31% compared to chemotherapy alone at a minimum follow-up of 8.1 months [Hazard Ratio (HR): 0.69, 96.71% Confidence Interval (CI): 0.55 to 0.87; p=0.0006]. Additionally, with longer follow-up (minimum of 12.7 months), the combination continued to show sustained OS improvements over chemotherapy alone (median OS of 15.6 months versus 10.9 months, respectively [HR: 0.66, 95% CI: 0.55 to 0.80]).
The clinical benefit was observed across all efficacy measures in key population subgroups, including by PD-L1 expression and tumor histology (squamous or non-squamous). The safety profile of Opdivo (360 mg every three weeks) plus Yervoy (1 mg/kg every six weeks) and two cycles of chemotherapy was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC. These results (Abstract #9501) will be featured in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting 2020, held virtually, from May 29-31.
With a minimum follow-up of 12.7 months, Opdivo plus Yervoy with limited chemotherapy improved OS regardless of PD-L1 expression levels, reducing the risk of death by 38% in patients with PD-L1 less than 1% (HR: 0.62, 95% CI: 0.45 to 0.85) and by 36% in patients with PD-L1 greater than 1% (HR: 0.64, 95% CI: 0.50 to 0.82). In addition, the dual immunotherapy and chemotherapy combination demonstrated a one-year PFS rate of 33% versus 18% for chemotherapy (HR: 0.68, 95% CI: 0.57 to 0.82), and an ORR of 38% compared to 25% with chemotherapy alone.