Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis

Jie Wang; Yi-Long Wu; Shun Lu; Qun Wang; Shanqing Li; Wen-Zhao Zhong; Qiming Wang; Wei Li; Buhai Wang; Jun Chen; Ying Cheng; Hongbing Duan; Gaofeng Li; Li Shan; Yangbo Liu; Jing Liu; Xiangning Huang; Ana Bolanos; Jie He

doi:10.1016/j.jtocrr.2023.100621

Adjuvant Osimertinib in Patients With Stage IB to IIIA EGFR Mutation-Positive NSCLC After Complete Tumor Resection: ADAURA China Subgroup Analysis

JTO Clin Res Rep. 2023 Dec 17;5(2):100621. doi: 10.1016/j.jtocrr.2023.100621. eCollection 2024 Feb.

Authors

Jie Wang¹, Yi-Long Wu², Shun Lu³, Qun Wang⁴, Shanqing Li⁵, Wen-Zhao Zhong², Qiming Wang⁶, Wei Li⁷, Buhai Wang⁸, Jun Chen⁹, Ying Cheng¹⁰, Hongbing Duan¹¹, Gaofeng Li¹², Li Shan¹³, Yangbo Liu¹⁴, Jing Liu¹⁴, Xiangning Huang¹⁵, Ana Bolanos¹⁶, Jie He¹⁷

Affiliations

¹ Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
² Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, People's Republic of China.
³ Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
⁴ Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
⁵ Department of Thoracic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
⁶ Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, People's Republic of China.
⁷ The First Hospital of Jilin University, Changchun, Jilin, People's Republic of China.
⁸ Department of Oncology of Subei People's Hospital, Yangzhou University, Yangzhou, Jiangsu, People's Republic of China.
⁹ Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, People's Republic of China.
¹⁰ Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, People's Republic of China.
¹¹ Zhongshan Hospital, Xiamen University, Xiamen, People's Republic of China.
¹² Department of Thoracic Surgery II, Yunnan Cancer Hospital, Kunming, People's Republic of China.
¹³ Xinjiang Medical University Affiliated Cancer Hospital, Urumqi, People's Republic of China.
¹⁴ Research & Development China, AstraZeneca, Shanghai, People's Republic of China.
¹⁵ Oncology Biometrics, AstraZeneca, Cambridge, United Kingdom.
¹⁶ Oncology Research & Development, AstraZeneca, Mississauga, Ontario, Canada.
¹⁷ Thoracic Surgery Department, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.

Abstract

Introduction: In Chinese patients with NSCLC, prevalence of EGFR-mutated (EGFRm) disease is high. In the global phase 3 ADAURA study (NCT02511106), adjuvant osimertinib was found to have a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus placebo in resected stage IB to IIIA EGFRm NSCLC. We present efficacy and safety data from a subgroup analysis of 159 Chinese patients enrolled in the People's Republic of China from ADAURA.

Methods: In ADAURA, patients with completely resected stage IB to IIIA EGFRm (exon 19 deletion/exon 21 L858R) NSCLC were randomized 1:1 to receive osimertinib (80 mg once daily) or placebo for 3 years or until disease recurrence/discontinuation. Adjuvant chemotherapy was permitted before randomization, per physician/patient choice. Primary end point was investigator-assessed DFS in stage II to IIIA disease; secondary end points included DFS in stage IB to IIIA (overall population), overall survival, health-related quality of life (HRQoL), and safety.

Results: Of 682 patients enrolled globally, 159 patients in the People's Republic of China were included in this subgroup analysis (osimertinib n = 77; placebo n = 82). Baseline characteristics were balanced across the treatment arms. At data cutoff, stage II to IIIA DFS hazard ratio (HR) was 0.23 (95% confidence interval [CI]: 0.13-0.42; maturity 59%); stage IB to IIIA DFS HR was 0.29 (95% CI: 0.17-0.48; maturity 42%). At 13% maturity (21 deaths), HR for overall survival in the stage IB to IIIA population was 0.51 (95% CI: 0.21-1.20). HRQoL was maintained from baseline, and safety was consistent with the global population.

Conclusions: In this population of Chinese patients from ADAURA, adjuvant osimertinib was found to have a clinically meaningful improvement in DFS versus placebo, with maintained HRQoL and a safety profile consistent with the global study population.

Keywords: Adjuvant; China; EGFR; NSCLC; Osimertinib.