Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer

作者：Shun Lü, Yongfeng Yu, Jianya Zhou, Xingya Li, Kōichi Goto, Xuhong Min, Kazumi Nishino, Jiuwei Cui, Lingnan Wu, Jun Sakakibara, Yongqian Shu, Xiaorong Dong, Li Lü, Yasuto Yoneshima, Chengzhi Zhou, Xiaoling Li, Yiping Zhang, Dingzhi Huang, Aimin Zang, Wei Zhang, Xiuwen Wang, Li Zhang, Chong Bai, Jian Fang, Lejie Cao, Yanqiu Zhao, Yan Yu, Meiqi Shi, Diansheng Zhong, Fugen Li, Wenhao Duanmu, Yibin Wang · 发表于：Translational Lung Cancer Research · 年份：2025 · DOI：10.21037/tlcr-2025-638 · 被引用次数：2 · 研究领域：Lung Cancer Treatments and Mutations、Melanoma and MAPK Pathways、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis

Background: Gumarontinib has previously shown activity in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation (METex14). We hereby report the updated results from the phase II stage of GLORY study after additional 18-month follow-up. Methods: The single-arm, multicenter, open-label, phase II of the GLORY study was conducted at 42 centers across China and Japan. Patients with locally advanced or metastatic METex14-positive NSCLC received gumarontinib 300 mg orally once daily until disease progression or intolerable toxicity. Eligible patients had failed one or two prior lines of therapy (not including a MET inhibitor) and had no genetic alterations targetable with standard therapies. The primary endpoint was the objective response rate (ORR) by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors version 1.1. The study was registered at ClinicalTrials.gov (NCT04270591). Results: The phase II stage of GLORY study included 84 patients. As of the data cutoff date on October 28, 2023, the ORR assessed by BIRC was 65.8% [95% confidence interval (CI): 54.3% to 76.1%], with 70.5% (95% CI: 54.8% to 83.2%) in treatment-naïve and 60.0% (95% CI: 42.1% to 76.1%) in pre-treated populations. The median duration of response (DOR) assessed by BIRC was 8.3 (95% CI: 6.2 to 18.3) months, the median progression-free survival (PFS) was 7.7 (95% CI: 7.6 to 9.7) months, and the median overall survival (OS) was 19.4 (95%...