Nivolumab, a fully human PD-1 immune checkpoint inhibitor antibody, demonstrated a favorable efficacy and safety profile in previously treated SQ NSCLC in a phase 3 trial (CheckMate 017), with significantly longer OS (median 9.2 mo) and fewer treatment-related (TR) grade 3–4 AEs (7%) vs. docetaxel (median OS: 6.0 mo; grade 3–4 TRAEs: 55%). In a North American community-based study (CheckMate 153; SQ/non-SQ NSCLC), nivolumab showed comparable efficacy and safety to that observed in controlled clinical trials.
Patients aged ≥18 yr from 13 European countries with advanced SQ NSCLC, progressive disease after ≥1 systemic treatment, and ECOG performance status (PS) 0–2 were eligible to receive nivolumab. The primary objective of the study (NCT02409368) was to evaluate safety. OS and ORR were secondary objectives.
809 patients were enrolled: 79% male and 93% current/former smokers. Most patients had received 1 (42%) or 2 (40%) prior lines of therapy. Median duration of nivolumab therapy was 4.4 mo (range: 0.0, >14.7). 324 patients (40%) were continuing treatment at database lock. 403 patients (50%) had TRAEs. 95 (12%) had grade 3–4 TRAEs, most frequently asthenia (12 [2%]) and fatigue (10 [1%]). Of the 5 cases (1%) of TR grade 3–4 pneumonitis, 3 had a documented resolution, and in these patients, resolution occurred within 5 wk. TRAEs led to treatment discontinuation in 45 patients (6%), most commonly pneumonitis, asthenia, and fatigue (7, 5, and 5 patients each). 2 deaths were deemed TR. Median OS was 9.9 mo (95% CI: 8.7, 13.1). In the subgroup aged ≥70 yr (n = 279), 155 patients (56%) had TRAEs and 16 (6%) discontinued due to TRAEs. In the subgroup with ECOG PS 2 (n = 98), 45 patients (46%) had TRAEs and 5 (5%) discontinued due to TRAEs. Additional data including outcomes in the age ≥70 yr and ECOG PS 2 subgroups will be presented.
The safety of nivolumab in this study was consistent with prior studies of nivolumab in previously treated SQ NSCLC, with no new safety signals. Tolerability in patients aged ≥70 yr or with ECOG PS 2 was comparable to the overall population.
Clinical trial identification
Legal entity responsible for the study
Bristol-Myers Squibb and Ono
S. Popat: Honoraria from Merck, Pfizer; served as a consultant/advisor for BI, Eli Lilly, Novartis, Roche, Pfizer (Inst), BI (Inst), BMS (Inst), MSD (Inst); received institutional research funding from BI, Roche, BMS, Clovis; travel: BI, MSD, BMS. A. Ardizzoni: Honoraria from Eli Lilly, BMS, MSD, BI; served as a consultant/advisor for Eli Lilly, BMS, MSD, BI, GSK. T. Ciuleanu: Advisor for Amgen, Astellas, AZ, BI, BMS, Eli Lilly, Ipsen, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanoi, Serono, Servier, Teva. R. Califano: Consultant/advisor for AstraZeneca, Roche, Clovis Oncology, Novartis, and Pfizer. R. Griffiths: Teaching honoraria from Bristol-Myers Squibb. W. Appel: Consultant or advisor for Amgen, AstraZeneca, and Boehringer Ingelheim; travel funding from Amgen. J. Wolf: Personal fees from University Hospital of Cologne; grants and personal fees from AZ, Novartis, Roche, Pfizer, BI, BMS, Clovis, and nonfinancial support from Novartis, Roche, BI, outside of the submitted work. J. Jiang, L.R. Molife: Employed by BMS and owns stock in BMS. E. Felip Font: Honoraria from BI, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene; Consultant for BI, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene; participated on speakers’ bureau for BMS, Novartis, and Roche. All other authors have declared no conflicts of interest.