Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy

Jong Seok Lee; Ki Hyeong Lee; Eun Kyung Cho; Dong-Wan Kim; Sang-We Kim; Joo-Hang Kim; Byoung Chul Cho; Jin Hyoung Kang; Ji-Youn Han; Young Joo Min; Keunchil Park

doi:10.1016/j.lungcan.2018.05.023

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Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy

Authors: Jong Seok Lee ; Ki Hyeong Lee ; Eun Kyung Cho ; Dong-Wan Kim ; Sang-We Kim ; Joo-Hang Kim ; Byoung Chul Cho ; Jin Hyoung Kang ; Ji-Youn Han ; Young Joo Min ; Keunchil Park

Citation: LUNG CANCER, Vol.122 : 234-242, 2018-08

Journal Title: LUNG CANCER

ISSN: 0169-5002

Issue Date: 2018-08

MeSH: Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents / therapeutic use* ; Carcinoma, Non-Small-Cell Lung / drug therapy* ; Carcinoma, Non-Small-Cell Lung / epidemiology ; Carcinoma, Non-Small-Cell Lung / mortality ; Drug Resistance, Neoplasm ; Drug-Related Side Effects and Adverse Reactions / epidemiology* ; Female ; Follow-Up Studies ; Humans ; Korea / epidemiology ; Lung Neoplasms / drug therapy* ; Lung Neoplasms / epidemiology ; Lung Neoplasms / mortality ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Nivolumab / therapeutic use* ; Platinum Compounds / therapeutic use ; Pneumonia / epidemiology* ; Pneumonia / etiology ; Prospective Studies ; Survival Analysis

Keywords: Nivolumab ; Non-small cell lung cancer ; Programmed cell death-1

Abstract: 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.