442P - Safety of nivolumab in patients with advanced or metastatic non-small cell lung cancer who have received at least one prior systemic regimens: Expanded access program in Korea (ONO-4538-X04)

Abstract

Background: Nivolumab, a fully human programmed death PD-1 immune checkpoint inhibitor antibody, has been approved in Korea for the treatment of advanced non–small-cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. We have assessed the safety of nivolumab in 299 patients with previously treated, advanced or metastatic NSCLC who were enrolled in the NSCLC expanded access program (EAP) in Korea. Methods: Our EAP included subjects with histologically documented NSCLC who have progressed after systemic treatment with a minimum of 1 prior systemic treatment for stage IIIB/IV disease. Unlike Checkmate-017 and 057, our EAP also included subjects with ECOG performance status (PS) of 2 and with two or more prior systemic treatments (heavily treated patients). Subjects were treated with 3 mg/kg of nivolumab IV every 2 weeks for a maximum of 24 months. Each 14-day dosing period constituted a single cycle. Patients included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using NCI CTC version 4.0. Results: As of September 1, 2017 (DLP: data lock point), 333 NSCLC patients participated from 36 hospitals in Korea. Out of 333, 299 patients received nivolumab and 206 (68.9%) were male. 21 (7.0%) were current smokers and 169 (56.5%) were former smokers. 86 (28.8%) had squamous, 212 (70.9%) had non-squamous and 1 (0.3%) had adenosquamous histology. 49 (16.4%) had PS 0, 212 (70.9%) had PS 1 and 38 (12.7%) had PS 2. 116 patients (38.8%) were heavily treated before (3rd line or more). At DLP, 40 patients were still receiving nivolumab treatments, whereas 259 patients had discontinued the treatment. Respiratory complication was the most frequent (39.6% any grade and 7.7% grade 3 or greater) treatment-emergent AE (TEAE). There were 118 patients (39.5%) who reported any treatment related adverse events (TRAEs) and 24 patients (8.0%) reported grade 3 or greater (table). 18 patients (6.0%) discontinued due to AEs.Table: 442P Treatment related adverse events reported in > 1% of patientsEventsAll GradesGrade 3 to 4Rash26 (8.7%)2 (0.7%)Pruritus14 (4.7%)0Fatique13 (4.3%)1 (0.3%)Diarrhea11 (3.7%)0Nausea8 (2.7%)1 (0.3%)Decreased appetite8 (2.7%)0Hypothyroidism8 (2.7%)0Pneumonia7 (2.3%)2 (0.7%)Pneumonitis5 (1.7%)2 (0.7%)Dyspnea5 (1.7%)1 (0.3%)Hyperthyroidism5 (1.7%)0Asthenia4 (1.3%)0Pyrexia4 (1.3%)1 (0.3%)Constipation4 (1.3%)0Oedema peripheral4 (1.3%)0 Open table in a new tab Conclusions: The results demonstrate that Korean EAP participants had safety profile similar to those previously reported in Checkmate-017 and Checkmate-057 studies, which strongly support the practical use of nivolumab for Korean NSCLC patients. Clinical trial indentification: ONO-4538-X04 Legal entity responsible for the study: Ono Pharmaceutical Funding: Ono pharmaceutical Disclosure: All authors have declared no conflicts of interest.