Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer

Shen Zhao, Wu Zhuang, Baohui Han, Zhengbo Song, Wei Guo, Feng Luo, Lin Wu, Yi Hu, Huijuan Wang, Xiaorong Dong, Da Jiang, Mingxia Wang, Liyun Miao, Qian Wang, Junping Zhang, Zhenming Fu, Yihua Huang, Chunwei Xu, Longyu Hu, Lei Li, Rong Hu, Yang Yang, Mengke Li, Xiugao Yang (), Li Zhang (), Yan Huang () and Wenfeng Fang ()
Additional contact information
Shen Zhao: Sun Yat-sen University Cancer Center
Wu Zhuang: Fujian Cancer Hospital
Baohui Han: Shanghai Chest Hospital
Zhengbo Song: Zhejiang Cancer Hospital
Wei Guo: Shanxi Provincial Cancer Hospital
Feng Luo: Sichuan University
Lin Wu: Hunan Cancer Hospital
Yi Hu: Chinese PLA General Hospital
Huijuan Wang: Henan Cancer Hospital
Xiaorong Dong: Huazhong University of Science and Technology
Da Jiang: The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Mingxia Wang: The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Liyun Miao: the Affiliated Hospital of Nanjing University Medical School
Qian Wang: Jiangsu Province Hospital of Chinese Medicine
Junping Zhang: Shanxi Bethune Hospital
Zhenming Fu: Renmin Hospital of Wuhan University
Yihua Huang: Sun Yat-sen University Cancer Center
Chunwei Xu: Nanjing University School of Medicine
Longyu Hu: HaploX Biotechnology Co,. Ltd.
Lei Li: CSPC Pharmaceutical Group Co., Ltd
Rong Hu: CSPC Pharmaceutical Group Co., Ltd
Yang Yang: CSPC Pharmaceutical Group Co., Ltd
Mengke Li: CSPC Pharmaceutical Group Co., Ltd
Xiugao Yang: CSPC Pharmaceutical Group Co., Ltd
Li Zhang: Sun Yat-sen University Cancer Center
Yan Huang: Sun Yat-sen University Cancer Center
Wenfeng Fang: Sun Yat-sen University Cancer Center

Nature Communications, 2023, vol. 14, issue 1, 1-16

Abstract: Abstract EGFR exon 20 insertion (20ins)-positive non-small-cell lung cancer (NSCLC) is an uncommon disease with limited therapeutic options and dismal prognosis. Here we report the activity, tolerability, potential mechanisms of response and resistance for dual targeting EGFR 20ins with JMT101 (anti-EGFR monoclonal antibody) plus osimertinib from preclinical models and an open label, multi-center phase 1b trial (NCT04448379). Primary endpoint of the trial is tolerability. Secondary endpoints include objective response rate, duration of response, disease control rate, progression free survival, overall survival, the pharmacokinetic profile of JMT101, occurrence of anti-drug antibodies and correlation between biomarkers and clinical outcomes. A total of 121 patients are enrolled to receive JMT101 plus osimertinib 160 mg. The most common adverse events are rash (76.9%) and diarrhea (63.6%). The confirmed objective response rate is 36.4%. Median progression-free survival is 8.2 months. Median duration of response is unreached. Subgroup analyses were performed by clinicopathological features and prior treatments. In patients with platinum-refractory diseases (n = 53), confirmed objective response rate is 34.0%, median progression-free survival is 9.2 months and median duration of response is 13.3 months. Responses are observed in distinct 20ins variants and intracranial lesions. Intracranial disease control rate is 87.5%. Confirmed intracranial objective response rate is 25%.

Date: 2023
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DOI: 10.1038/s41467-023-39139-4

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