2 YEAR SURVIVAL DATA WITH NIVOLUMAB IN NSCLC

Analysis of 2-year overall survival with nivolumab (Opdivo) vs docetaxel in the phase III CheckMate 017 and 057 trials showed a continued survival benefit with nivolumab in patients with previously treated advanced non–small cell lung cancer (NSCLC). The findings were reported by Horn et al in the Journal of Clinical Oncology. Nivolumab prolonged survival in the primary analysis from both trials.

Study Details

In the 2 open-label trials, patients with stage IIIB or IV squamous (n = 272, CheckMate 017) or nonsquamous (n = 582, CheckMate 057) NSCLC and disease progression during or after platinum-based chemotherapy were randomized to receive nivolumab at 3 mg/kg every 2 weeks (CheckMate 017, n = 135; CheckMate 057, n = 292) or docetaxel at 75 mg/m2 every 3 weeks (CheckMate 017, n = 137; CheckMate 057, n = 290).

2-Year Outcomes

Minimum follow-up for survival was 24.2 months. Overall survival at 2 years was 23% among nivolumab patients vs 8% among docetaxel patients with squamous NSCLS and 29% vs 16% among patients with nonsquamous NSCLC. As in the primary analysis of the trials, the benefit of nivolumab vs docetaxel was observed independent of programmed cell death ligand 1 (PD-L1) expression in squamous NSCLC; among patients with nonsquamous disease, the benefit of nivolumab was greater in those with higher levels of PD-L1 but still present in patients with PD-L1 expression < 1%.

Overall, 10 of 27 (37%) nivolumab patients with squamous NSCLC who had a confirmed response and 19 of 56 (34%) patients with nonsquamous NSCLC with a confirmed response had ongoing responses after a minimum follow-up of 2 years. No docetaxel patients had an ongoing response. In pooled analysis of both trials, median overall survival was 11.1 months in nivolumab patients vs 8.1 months in docetaxel patients (hazard ratio = 0.72, 95% confidence interval [CI] = 0.62–0.84). Hazard ratios were 0.42 (95% CI = 0.28–0.63) in patients with ≥ 50% PD-L1 expression and 0.78 (95% CI = 0.61–0.99) in those with < 1% PD-L1 expression.

Treatment-related adverse events of any grade occurred in 68% of nivolumab patients vs 88% of docetaxel patients, with grade 3 or 4 events occurring in 10% vs 55%, respectively. Treatment-related immune-related adverse events occurred in 37% of nivolumab patients, including grade 3 or 4 events in 5%.

The investigators concluded: “Nivolumab provides long-term clinical benefit and a favorable tolerability profile compared with docetaxel in previously treated patients with advanced NSCLC.”

The study was supported by Bristol-Myers Squibb.

Leora Horn, MD, of the Vanderbilt-Ingram Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.