Objectives: To investigate the efficacy and safety of nivolumab in Korean patients with stage IIIB/IV or recurrent non-small-cell lung cancer (NSCLC) who failed platinum-based chemotherapy. Materials and methods: In this multicenter, open-label, Phase II study, 100 patients with stage IIIB or IV squamous (n = 44) or non-squamous (n = 56) NSCLC received nivolumab 3 mg/kg every 2 weeks for 6 weeks per treatment cycle. Patients continued treatment until disease progression or intolerable adverse events (AEs), and then entered a follow-up phase. The primary efficacy endpoint was the centrally assessed objective response rate (ORR). Results: The ORR was 20.0% (95% confidence interval [CI]: 13.3–28.9%) in the total population, 15.9% (7/44 patients; 95% CI: 7.9–29.4%) in patients with squamous NSCLC, and 23.2% (13/56 patients; 95% CI: 14.1–35.8%) in patients with non-squamous NSCLC. Median overall survival was 13.9 (95% CI: 10.8–18.5) months in the total population, 12.3 (95% CI: 8.2–18.5) months in squamous NSCLC, and 16.3 (95% CI: 10.8, −) months in non-squamous NSCLC. Median progression-free survival was 2.8 (95% CI: 1.4–5.7), 2.6 (95% CI: 1.3–5.7), and 5.3 (95% CI: 1.4–7.1) months in the total, squamous, and non-squamous NSCLC populations, respectively. The median duration of response was 11.7 (95% CI: 5.6, −), 12.0 (95% CI: 4.8, −), and 12.1 (95% CI: 3.0, −) months in the total, squamous, and non-squamous NSCLC populations, respectively. The most frequent AEs were decreased appetite, dyspnea, and cough in 43 (43.0%), 32 (32.0%), and 29 (29.0%) patients, respectively. The most common Grade ≥3 AE was pneumonia, occurring in 7.0% of patients. Common treatment-related AEs included decreased appetite (14.0%) and pruritus (6.0%), neither of which was Grade ≥3. Conclusion: The efficacy and safety of nivolumab in Korean patients with advanced or recurrent squamous or non-squamous NSCLC are consistent with previous reports.
Bibliographical noteFunding Information:
All authors report receiving grants from Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company during the conduct of the study. Dr. Byoung Chul Cho also reports receiving research funding from Novartis, Bayer, AstraZeneca, the MOGAM Institute, and Dong-A ST, and performing consulting roles for Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, Yuhan, Pfizer, and Eli Lilly. Dr. Jin Hyoung Kang also reports receiving honoraria from Bristol-Myers Squibb and Boehringer Ingelheim, research funding from AstraZeneca and Eli Lilly, and performing consulting or advisory roles for Bristol-Myers Squibb. Dr. Keunchil Park also reports receiving grants and personal fees from AstraZeneca, personal fees from BMS, personal fees from Roche, and personal fees from MSD, outside the submitted work.
This study was supported by Ono Pharmaceutical Co., Ltd. The study sponsor contributed to the design of the study, was involved in the collection, analysis and interpretation of data, in the writing of the manuscript, and in the decision to submit the manuscript for publication.
All Science Journal Classification (ASJC) codes
- Pulmonary and Respiratory Medicine
- Cancer Research