CheckMate 153 (NCT02066636) is an ongoing, predominantly community-based, phase 3B/4 safety study of nivolumab in patients with previously treated metastatic NSCLC in the US/Canada. Here we report safety, efficacy, and patient-reported outcome (PRO) data for subgroups of patients aged ≥70 years or with a poor baseline ECOG PS (PS2). Patients were enrolled in four subgroups based on histology and prior regimen number; one subgroup enrolled patients with squamous (SQ) or non-SQ NSCLC, PS2, and ≥1 prior therapies. Data on elderly patients were pooled across subgroups. The primary objective was assessment of high-grade (grade 3–4 and 5) select (those with a potential immunologic cause) treatment-related AE (TRAE) incidences. Exploratory endpoints included efficacy, biomarkers, pharmacokinetics, and PROs. Of 1,308 patients, 520 (40%) were aged ≥70 years and 108 (8%) had PS2. TRAE incidences for the age and PS subgroups were comparable with those for the overall population (table), as were select TRAE incidences for the subgroups. Estimated 6-month OS was lower with PS2 than PS0‒1, but similar between age subgroups and the overall population (table). Early PRO data revealed significant improvements overall in both age subgroups using LCSS and EQ-5D VAS, with younger patients showing greater improvement on some scales. Patients with SQ disease and PS2 generally reported stable quality-of-life/symptom control, whereas patients with non-SQ disease had statistically significant improvements on most scales. Updated data, including 1-year OS, will be presented. In this large study of advanced, previously treated, predominantly community-based patients with NSCLC, the nivolumab safety profile for age and PS subgroups was comparable with those for the overall population and from prior nivolumab NSCLC studies. OS was similar in younger and older patients, but lower in PS2 patients at early time points. Nivolumab appears to have similar risks/benefits in older and poorer PS patients as in the general population.
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