Nivolumab, a fully human anti-programmed death-1 antibody, demonstrated improved overall survival (OS) and a favorable safety profile versus docetaxel in previously treated advanced squamous NSCLC in a phase 3 trial (CheckMate 017). Here, we present findings from a single-arm phase 2 study of nivolumab in patients with previously treated advanced squamous NSCLC (CheckMate 171; NCT02409368).
Patients aged ≥18 years from 13 European countries, with advanced squamous NSCLC, progressive disease after ≥1 systemic treatment, and ECOG performance status (PS) 0–2 were eligible to receive nivolumab. The primary objective was safety evaluation; OS was a secondary objective.
Of 809 patients enrolled, 79% were male and 93% were current/former smokers. Most patients had received 1 (42%) or 2 (40%) prior lines of therapy. Median (range) duration of nivolumab therapy was 4.4 (0-14.7+) months. At database lock, 324 (40%) patients were continuing treatment. Treatment-related adverse events (TRAEs) occurred in 403 (50%) patients, including grade 3–4 TRAEs in 95 (12%) patients, most frequently asthenia (n=12, 2%) and fatigue (n=10, 1%). Five (1%) patients had treatment-related grade ≥3 pneumonitis. Forty-five (6%) patients discontinued due to TRAEs, most commonly pneumonitis (n=7), asthenia (n=5), and fatigue (n=5); 3 deaths were considered treatment-related. Median OS was 9.9 months (95% CI: 8.7, 13.1). Of 279 patients aged ≥70 years, 155 (56%) had TRAEs and 16 (6%) discontinued due to TRAEs. Of 98 patients with ECOG PS=2, 45 (46%) had TRAEs and 5 (5%) discontinued due to TRAEs. Additional data including outcomes in these two subgroups will be presented.
The safety of nivolumab in this study was consistent with prior studies of nivolumab in previously treated squamous NSCLC, with no new safety signals. Tolerability in patients aged ≥70 years or with ECOG PS=2 was comparable to the overall population.