Evidence map›Paper›PMID 37308490›Full record

ArticleNature communications2023

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 and 17 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04448379 (A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04448379 phase1unknown statusnot on this map

A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

TypeinterventionalSponsorShanghai JMT-Bio Inc.Ran2020 to 2022Enrolled48ConditionsLocally Advanced or Metastatic Non-Small Cell Lung CancerArmsJMT101
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Review
  2. Article
  3. Current paradigm of EGFRMed (New York, N.Y.) · 2025
    Review
  4. Article
  5. Review
  6. Review
  7. Translational lung cancer research · 2024
    Article
  8. [EGFR Exon 20 Insertion Mutation: Research Status and New Treatment Strategies].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2024
    Review
  9. Article
  10. Bispecific antibody drug conjugates: Making 1+1>2.Acta pharmaceutica Sinica. B · 2024
    Review
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Shen Zhao *Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
Wu Zhuang *Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China.
Baohui Han *Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai, China.
Zhengbo Song *Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Wei Guo *Department of Respiratory Medicine, Shanxi Provincial Cancer Hospital, Taiyuan, China.ORCID 0000-0002-1923-6975
Feng Luo *Lung Cancer Center, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, China.
Lin WuDepartment of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China.
Yi HuDepartment of Medical Oncology, Chinese PLA General Hospital, Beijing, China.
Huijuan WangDepartment of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.
Xiaorong DongCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Da JiangDepartment of Medical Oncology, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, China.
Mingxia WangDepartment of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, China.
Liyun MiaoDepartment of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Qian WangDepartment of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Junping ZhangDepartment of Medical Oncology, Shanxi Bethune Hospital, Taiyuan, China.
Zhenming FuCancer Center, Renmin Hospital of Wuhan University, Wuhan, China.
Yihua HuangDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
Chunwei XuDepartment of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Longyu HuHaploX Biotechnology Co,. Ltd., Shenzhen, China.
Lei LiClinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Rong HuClinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Yang YangClinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Mengke LiClinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China.
Xiugao YangClinical Science Division, CSPC Pharmaceutical Group Co., Ltd, Shijiazhuang, China. yangxiugao@cspc.cn.
Li ZhangDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. zhangli@sysucc.org.cn.
Yan HuangDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. huangyan@sysucc.org.cn.
Wenfeng FangDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. fangwf@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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%.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAniline CompoundsAntibodies, MonoclonalExonsHumansIndolesPyrimidinesAcrylamidesAniline CompoundsAntibodies, MonoclonalIndolesosimertinibPyrimidines

Identifiers

PMID37308490
PMCPMC10261012

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.