Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations

Shun Lu, MD; Jian Fang, MD; Xingya Li, MD; Lejie Cao, MD; Jianying Zhou, MD; Qisen Guo, MD; Zongan Liang, MD; Ying Cheng, MD; Liyan Jiang, MD; Nong Yang, MD; Zhigang Han, MD; Jianhua Shi, MD; Yuan Chen, MD; Hua Xu, MD; Helong Zhang, MD; Gongyan Chen, MD; Rui Ma, MD; Sanyuan Sun, MD; Yun Fan, MD; Songhua Fan, MD; Jie Yu, MD; Puhan Lu, PhD; Xian Luo, MS; Weiguo Su, PhD

JTO Clinical and Research Reports (Oct 2022)

Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations

Shun Lu, MD,
Jian Fang, MD,
Xingya Li, MD,
Lejie Cao, MD,
Jianying Zhou, MD,
Qisen Guo, MD,
Zongan Liang, MD,
Ying Cheng, MD,
Liyan Jiang, MD,
Nong Yang, MD,
Zhigang Han, MD,
Jianhua Shi, MD,
Yuan Chen, MD,
Hua Xu, MD,
Helong Zhang, MD,
Gongyan Chen, MD,
Rui Ma, MD,
Sanyuan Sun, MD,
Yun Fan, MD,
Songhua Fan, MD,
Jie Yu, MD,
Puhan Lu, PhD,
Xian Luo, MS,
Weiguo Su, PhD

Affiliations

Shun Lu, MD: Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People’s Republic of China; Corresponding author. Address for correspondence: Shun Lu, MD, Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, People’s Republic of China.
Jian Fang, MD: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Beijing, People’s Republic of China
Xingya Li, MD: Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
Lejie Cao, MD: Department of Respiratory Diseases, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei, People’s Republic of China
Jianying Zhou, MD: Department of Respiratory Diseases, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People’s Republic of China
Qisen Guo, MD: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People’s Republic of China
Zongan Liang, MD: Department of Respiratory and Critical Care Medicine, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, People’s Republic of China
Ying Cheng, MD: Department of Medical Thoracic Oncology, Jilin Cancer Hospital, Changchun, People’s Republic of China
Liyan Jiang, MD: Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China
Nong Yang, MD: Department of Lung Cancer and Gastroenterology, Hunan Cancer Hospital, The Affiliated Tumour Hospital of Xiangya Medical School of Central South University, Changsha, People’s Republic of China
Zhigang Han, MD: First Department of Lung Cancer Chemotherapy, The Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, People’s Republic of China
Jianhua Shi, MD: Department of Oncology, Linyi Cancer Hospital, Linyi, People’s Republic of China
Yuan Chen, MD: Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China
Hua Xu, MD: Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, People’s Republic of China
Helong Zhang, MD: Department of Oncology, Tangdu Hospital, Fourth Military Medical University, Xi'An, People’s Republic of China
Gongyan Chen, MD: Department of Medical Oncology, The Affiliated Tumour Hospital of Harbin Medical University, Harbin, People’s Republic of China
Rui Ma, MD: Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital, Shenyang, People’s Republic of China
Sanyuan Sun, MD: Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, People’s Republic of China
Yun Fan, MD: Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China
Songhua Fan, MD: HUTCHMED Limited, Shanghai, People’s Republic of China
Jie Yu, MD: HUTCHMED Limited, Shanghai, People’s Republic of China
Puhan Lu, PhD: HUTCHMED Limited, Shanghai, People’s Republic of China
Xian Luo, MS: HUTCHMED Limited, Shanghai, People’s Republic of China
Weiguo Su, PhD: HUTCHMED Limited, Shanghai, People’s Republic of China

Journal volume & issue: Vol. 3, no. 10
p. 100407

Abstract

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Introduction: Savolitinib has been found to have encouraging antitumor activity and a favorable safety profile in Chinese patients with pulmonary sarcomatoid carcinoma and other NSCLCs with MET exon 14 skipping alterations (MET ex14 positive) at the primary analysis of a phase 2 study. Here, we present the long-term efficacy and safety data of savolitinib, including subgroup analyses. Methods: This multicenter, single-arm, open-label, phase 2 study in the People’s Republic of China enrolled MET inhibitor-naive adults with locally advanced or metastatic METex14-positive NSCLC (NCT02897479). Oral savolitinib at a dose of 400 or 600 mg was administered once daily (body weight dependent). The primary objectives of the final analysis were long-term overall survival (OS) and subgroup analyses by previous systemic treatment, NSCLC subtypes, and brain metastases. Results: At the final analysis cutoff date (June 28, 2021), a total of 70 patients were enrolled and receiving savolitinib, and median follow-up was 28.4 (interquartile range: 26.2–36.3) months. The median OS was 12.5 months (95% confidence interval [CI]: 10.5–21.4 [18- and 24-mo OS rates, 42.1% and 31.5%, respectively]). Median OS in pretreated or treatment-naive patients was 19.4 (95% CI: 10.5–31.3) and 10.9 (95% CI: 7.5–14.0) months, respectively; it was 10.6 months (95% CI: 4.6–14.0) in patients with pulmonary sarcomatoid carcinoma, 17.3 months (95% CI: 10.6–23.6) in other NSCLC subtypes, and 17.7 months (95% CI: 10.5–not evaluable) in patients with brain metastases. No new safety signals emerged with prolonged follow-up and exposure. Conclusions: The updated results further confirm the favorable benefit and acceptable safety of savolitinib in Chinese patients with METex14-positive NSCLC.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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