An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870)

Shun Lu; Ying Cheng; Jianying Zhou; Mengzhao Wang; Jun Zhao; Baocheng Wang; Gongyan Chen; Jifeng Feng; Zhiyong Ma; Lin Wu; Changli Wang; Kewei Ma; Shucai Zhang; Jun Liang; Yong Song; Jie Wang; Yi-Long Wu; Ang Li; Yizhi Huang; Jianhua Chang

doi:10.1177/17588359221138380

An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870)

Ther Adv Med Oncol. 2022 Nov 19:14:17588359221138380. doi: 10.1177/17588359221138380. eCollection 2022.

Authors

Shun Lu¹, Ying Cheng², Jianying Zhou³, Mengzhao Wang⁴, Jun Zhao⁵, Baocheng Wang⁶, Gongyan Chen⁷, Jifeng Feng⁸, Zhiyong Ma⁹, Lin Wu¹⁰, Changli Wang¹¹, Kewei Ma¹², Shucai Zhang¹³, Jun Liang¹⁴, Yong Song¹⁵, Jie Wang¹⁶, Yi-Long Wu¹⁷, Ang Li¹⁸, Yizhi Huang¹⁹, Jianhua Chang²⁰

Affiliations

¹ Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, 241 Huaihai West Road, Xuhui District, Shanghai, China.
² Jilin Cancer Hospital, Changchun, China.
³ The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
⁴ Peking Union Medical College Hospital, Beijing, China.
⁵ Beijing Cancer Hospital, Beijing, China.
⁶ Jinan Military General Hospital, Jinan, China.
⁷ Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.
⁸ Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.
⁹ Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
¹⁰ Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University), Changsha, China.
¹¹ Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
¹² The First Hospital of Jilin University, Changchun, China.
¹³ Beijing Chest Hospital, Beijing, China.
¹⁴ Peking University International Hospital, Beijing, China.
¹⁵ Nanjing General Hospital, Nanjing, China.
¹⁶ National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
¹⁷ Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
¹⁸ Bristol Myers Squibb Company, Princeton, NJ, USA.
¹⁹ Bristol-Myers Squibb, Shanghai, China.
²⁰ Shanghai Cancer Center Fudan University, Shanghai, China.

Abstract

Background: Nivolumab has been approved in China as second-line treatment for advanced non-small-cell lung cancer (NSCLC) via weight-based infusion, based on the CheckMate 078 study. We investigated the safety and efficacy of 240 mg flat-dose nivolumab in patients with advanced NSCLC, including those with hepatitis B virus (HBV) and epidermal growth factor receptor (EGFR) mutation/ALK receptor tyrosine kinase (ALK) translocation due to high prevalence in China.

Methods: CheckMate 870 was a single-arm, open-label, phase IIIb trial in Asian (primarily Chinese) patients with previously treated advanced NSCLC. Patients received flat-dose nivolumab 240 mg every 2 weeks (Q2W) for up to 2 years. The primary endpoint was the incidence and severity of treatment-related select adverse events (TRsAEs) in non-HBV patients; secondary and exploratory endpoints included severity of high-grade TRsAEs in HBV-infected patients, and safety, efficacy and patient-reported outcomes (PROs) in the whole population.

Results: Out of 404 patients enrolled, 400 received treatment. Median (standard deviation) age was 60.5 (8.68) years and the majority were male (78.5%). At a median follow-up of 37.6 months, no Grade 5 TRsAEs were reported, and the frequency of Grade 3-4 TRsAEs was low (0.0-5.9%) in non-HBV and HBV NSCLC patients. Median overall survival (OS) and progression-free survival (PFS) in all treated patients were 14.7 (12.3-18.1) and 3.6 (2.3-3.8) months, respectively. Median OS was 14.2 (12.3-18.1) and 22.3 (10.0-NA) months for non-HBV and HBV-infected patients, 19.3 (11.2-31.7) and 13.7 (11.5-18.1) months for EGFR-positive and wild-type subgroups, and 19.3 (12.9-23.5) and 13.3 (10.9-17.7) months for those with programmed death-ligand 1 (PD-L1) expression ⩾1% and <1%, respectively. No notable changes from baseline were observed in PROs throughout the study.

Conclusion: Nivolumab 240 mg infusion Q2W was well tolerated, efficacious, and maintained health status and quality of life in Asian patients with previously treated advanced NSCLC regardless of HBV, EGFR, or PD-L1 status.

Keywords: Chinese; EGFR mutation; NSCLC; Nivolumab; flat dosing; hepatitis B.