ASCO 2021: 2-Year Follow-up With Nivolumab/Ipilimumab Plus Chemotherapy for Advanced Lung Cancer
Posted: Thursday, June 17, 2021
First-line nivolumab plus ipilimumab along with chemotherapy for advanced non–small cell lung (NSCLC) improved outcomes compared with chemotherapy alone, according to Martin Reck, MD, PhD, of the German Center for Lung Research, Grosshansdorf, and colleagues. Findings from the CheckMate 9LA multinational phase III trial indicated that this immunotherapy combination to increased overall survival and objective response rates, regardless of PD-L1 expression and histopathology. These 2-year follow-up results were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9000).
A total of 719 ambulatory or fully active patients with stage 4, recurrent NSCLC and no sensitizing EGFR/ALK alterations were enrolled. Stratified by PD-L1 levels, sex, and histology, these patients were randomly assigned as follows: nivolumab (360 mg) for 3 weeks plus ipilimumab (1 mg/kg) for 6 weeks plus two cycles of chemotherapy (treatment group) or four cycles of chemotherapy alone (control group).
Median overall survival at a minimum follow-up of 24.4 months favored the addition of nivolumab and ipilimumab (15.8 months) over chemotherapy alone (11.0 months, hazard ratio [HR] = 0.72, 95% confidence interval [CI] = 0.61–0.86). The median progression-free survival was 6.7 months in the immunotherapy group compared with 5.3 months in the control group (HR = 0.67, 95% CI = 0.56–0.79). Of the patients who experienced disease progression, 8% in the control group and 37% in the group given nivolumab/ipilimumab received subsequent immunotherapy.
The overall response rate was also reduced in the chemotherapy-alone group (25%) compared with nivolumab plus ipilimumab (38%). These findings were consistent across all stratified groups, including PD-L1 levels and histology. Any-grade adverse events related to treatment were observed in 92% of those given nivolumab/ipilimumab and 48% of patients given chemotherapy alone; grade 3 or 4 events related to treatment were reported in 88% and 38%, respectively.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.