P2.04-39 Clinical Characteristics of Long-Term Survivors with Nivolumab in Previously Treated Advanced NSCLC from Real World Data

Abstract

Nivolumab, a programmed death-1 immune checkpoint inhibitor antibody, has become one of the new standard therapies for previously treated advanced non-small cell lung cancer (NSCLC). However, there is limited information about the long-term survival of real-world patients treated with nivolumab in Japan. We performed a retrospective study of previously treated patients with advanced NSCLC who received nivolumab at 3 mg/kg every 2 weeks outside clinical trials from our institution in Saitama (Japan) between January 2016 and February 2017. We used real-world data (RWD) to analyze the clinical characteristics of patients who were alive 2 years after initiating nivolumab treatment. A total of 129 patients fulfilled the inclusion criteria. Thirty-eight patients (30%) were alive 2 years after receiving the first dose of nivolumab. The median age at initial nivolumab treatment was 65 years (38–79). Twenty-nine (76%) patients were male, 12 (32%) were never-smokers, 37 (97%) had performance status (PS) 0 and 1, and 30 (79%) had adenocarcinoma histology. Twenty-five (66%) patients received nivolumab as second-line therapy, and 9 (24%) had genetic abnormalities including 7 with epidermal growth factor receptor (EGFR) mutations. Thirty-four cases of programmed death-ligand 1 expression in tumor samples were not quantifiable. The best responses to nivolumab per the Response Evaluation Criteria in Solid Tumors version 1.1 included 12 partial responses (32%) and 6 complete responses (16%). Eleven 2-year survivors (29%) received nivolumab for more than two years, three (8%) discontinued nivolumab because of immune-related adverse effects, and four (11%) were retreated. Fourteen 2-year survivors (37%) received only nivolumab without subsequent therapy and did not display evidence of progressive disease at the last follow-up. These survivors exhibited significantly good PS, were male, had a history of smoking, and did not harbour somatic genetic abnormalities. Multivariate analysis identified only good PS as an independent positive predictor of survival of two years or more. In our RWD experience, nivolumab resulted in a 2-year survival rate of 30% in previously treated patients with advanced NSCLC. The 2-year survival rate in a real-world clinical setting was slightly lower than that in a Japanese phase II study (ONO4538-05/06 study). Clinical characteristics associated with a positive treatment response were comparable to those observed in previous studies.