Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial
Jianchun Duan
1, 2, 3
,
Wei Lin
4
,
Lin Wu
5
,
Kunyu Yang
6, 7
,
Jun Zhao
8
,
Jun Zhao
9
,
Yanqiu Zhao
10, 11
,
Xiaoyang Dai
12
,
Xiumei Dai
13
,
Mingjun Li
14, 15
,
Yanyan Xie
16, 17
,
Yu Yang
18
,
Yu Yao
19
,
Mingfang Zhao
20, 21
,
Chengzhi Zhou
22
,
XIUBAO REN
23, 24
,
Zhe Li
25
,
Zhe Liu
26
,
Yue Yin Pan
27, 28
,
Yuping Li
29
,
Yuping Li
30
,
Baogang Liu
31, 32
,
Ying Cheng
33
,
Ying Cheng
34
,
Liyun Miao
35, 36
,
Yu Qian
37
,
Qitao Yu
38
,
Zhihong Zhang
39
,
Zhihong Zhang
40
,
Xiaoqing Liu
41
,
Jiuwei Cui
42
,
Jiu-Wei Cui
43
,
Z yu
44
,
Yu Zhang
45
,
Lubo Zhang
46
,
Li Zhang
47
,
Xiaoyan Li
48
,
Xiaoyan Li
49, 50
,
Xiaoling Li
51
,
Xiaoling Li
49, 50
,
Bo Shen
52
,
Bo Shen
53
,
Chongwen Bi
54
,
Bi Chen
55
,
Shan Zeng
56, 57
,
Bin Li
56
,
Bin Li
57
,
Yong Hu
58
,
Yanping Hu
59
,
Lin Li
60
,
Rong Wu
61
,
Qibin Song
62, 63
,
Jie Ying Wu
64
,
Jie Wang
2
3
4
Thoracic Department II, Hunan Cancer Hospital, Changsha, People's Republic of China.
|
5
Thoracic Department II, Hunan Cancer Hospital, Changsha 410031, China
|
6
Department of Head and Neck Oncology, Cancer Center, Wuhan Union Hospital, Wuhan, People's Republic of China.
|
7
Department of Head and Neck Oncology, Cancer Center, Wuhan Union Hospital, Wuhan 430000, China
|
12
Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, People's Republic of China.
|
13
Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou 221009, China
|
16
Clinical Cancer Center Oncology Department 1, Guangxi Zhuang Autonomous Region People's Hospital, Nanning, People's Republic of China.
|
17
Clinical Cancer Center Oncology Department 1, Guangxi Zhuang Autonomous Region People's Hospital, Nanning 530000, China
|
25
Department of Oncology, Beijing Chest Hospital, Beijing, People's Republic of China.
|
26
Department of Oncology, Beijing Chest Hospital, Beijing 101125, China
|
27
Department of Tumor Chemotherapy, Anhui Provincial Hospital, Hefei, People's Republic of China.
|
28
Department of Tumor Chemotherapy, Anhui Provincial Hospital, Hefei 230000, China
|
31
33
Department of Medical Oncology, Jilin Cancer Hospital, Changchun, People's Republic of China.
|
34
Department of Medical Oncology, Jilin Cancer Hospital, Changchun 130012, China
|
35
36
39
Department of Respiratory, Anhui Cancer Hospital, Hefei, People's Republic of China.
|
40
Department of Respiratory, Anhui Cancer Hospital, Hefei 230031, China
|
41
Department of Oncology, Fifth Medical Center, Liberation General Hospital, Beijing, People's Republic of China.
|
44
Department of Respiratory, Nanjing Chest Hospital, Nanjing, People's Republic of China.
|
45
Department of Respiratory, Nanjing Chest Hospital, Nanjing 210029, China
|
50
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,
51
Thoracic Medicine, Liaoning Cancer Hospital & Institute, Shenyang, People's Republic of China.
|
52
Medical Department, Jiangsu Cancer Hospital, Nanjing, People's Republic of China.
|
53
Medical Department, Jiangsu Cancer Hospital, Nanjing 210000, China
|
54
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Xuzhou Medical University, Xuzhou, People's Republic of China.
|
55
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Xuzhou Medical University, Xuzhou 220005, China
|
58
Department of Medical Oncology, Cancer Hospital of Hubei Province, Wuhan, People's Republic of China.
|
59
Department of Medical Oncology, Cancer Hospital of Hubei Province, Wuhan 430070, China
|
60
Department of Oncology, Beijing Hospital, Beijing, People's Republic of China.
|
Publication type: Journal Article
Publication date: 2024-02-01
scimago Q1
wos Q1
SJR: 7.948
CiteScore: 34.9
Impact factor: 20.8
ISSN: 15560864, 15561380
PubMed ID:
37776953
Oncology
Pulmonary and Respiratory Medicine
Abstract
Treatment options for treatment-naive patients with advanced NSCLC harboring EGFR exon 20 insertion (ex20ins) mutations are limited. This study evaluated the safety, tolerability, and pharmacokinetics of YK-029A, a third-generation EGFR tyrosine kinase inhibitor, and the preliminary efficacy of YK-029A in treatment-naive patients with EGFR ex20ins mutation.This multicenter, dose-escalation, and dose-expansion phase 1 clinical trial enrolled patients with NSCLC harboring EGFR mutations. During the dose-escalation phase, YK-029A was orally administered using the traditional 3+3 principle at 50, 100, 150, 200, and 250 mg/d. In the dose-expansion phase, treatment-naive patients with EGFR ex20ins mutations were enrolled and administered YK-029A 200 mg/d. The primary end point was safety and tolerability.The safety analysis included 108 patients. No dose-limiting toxicity was observed, and the maximum tolerated dose was not reached. The most common treatment-emergent adverse events were anemia (50.9%), diarrhea (49.1%), and rash (34.3%). There was minimal drug accumulation after multiple doses. A total of 28 treatment-naive patients with EGFR ex20ins mutations were enrolled in the dose-expansion and 26 were included in the efficacy analysis. According to the independent review committee evaluation, the objective response rate was 73.1% (95% confidence interval: 52.21%-88.43%), and the disease control rate was 92.3% (95% confidence interval: 74.87%-99.05%).YK-029A was found to have manageable safety and be tolerable in patients with NSCLC harboring EGFR mutations and have promising antitumor activity in untreated patients with EGFR ex20ins mutations.
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15
Total citations:
15
Citations from 2024:
15
(100%)
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GOST
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Duan J. et al. Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial // Journal of Thoracic Oncology. 2024. Vol. 19. No. 2. pp. 314-324.
GOST all authors (up to 50)
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Duan J. et al. Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial // Journal of Thoracic Oncology. 2024. Vol. 19. No. 2. pp. 314-324.
Cite this
RIS
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TY - JOUR
DO - 10.1016/j.jtho.2023.09.1449
UR - https://linkinghub.elsevier.com/retrieve/pii/S1556086423022591
TI - Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial
T2 - Journal of Thoracic Oncology
AU - Duan, Jianchun
AU - Lin, Wei
AU - Wu, Lin
AU - Yang, Kunyu
AU - Zhao, Jun
AU - Zhao, Jun
AU - Zhao, Yanqiu
AU - Dai, Xiaoyang
AU - Dai, Xiumei
AU - Li, Mingjun
AU - Xie, Yanyan
AU - Yang, Yu
AU - Yao, Yu
AU - Zhao, Mingfang
AU - Zhou, Chengzhi
AU - REN, XIUBAO
AU - Li, Zhe
AU - Liu, Zhe
AU - Pan, Yue Yin
AU - Li, Yuping
AU - Li, Yuping
AU - Liu, Baogang
AU - Cheng, Ying
AU - Cheng, Ying
AU - Miao, Liyun
AU - Qian, Yu
AU - Yu, Qitao
AU - Zhang, Zhihong
AU - Zhang, Zhihong
AU - Liu, Xiaoqing
AU - Cui, Jiuwei
AU - Cui, Jiu-Wei
AU - yu, Z
AU - Zhang, Yu
AU - Zhang, Lubo
AU - Zhang, Li
AU - Li, Xiaoyan
AU - Li, Xiaoyan
AU - Li, Xiaoling
AU - Li, Xiaoling
AU - Shen, Bo
AU - Shen, Bo
AU - Bi, Chongwen
AU - Chen, Bi
AU - Zeng, Shan
AU - Li, Bin
AU - Li, Bin
AU - Hu, Yong
AU - Hu, Yanping
AU - Li, Lin
AU - Wu, Rong
AU - Song, Qibin
AU - Wu, Jie Ying
AU - Wang, Jie
PY - 2024
DA - 2024/02/01
PB - Elsevier
SP - 314-324
IS - 2
VL - 19
PMID - 37776953
SN - 1556-0864
SN - 1556-1380
ER -
Cite this
BibTex (up to 50 authors)
Copy
@article{2024_Duan,
author = {Jianchun Duan and Wei Lin and Lin Wu and Kunyu Yang and Jun Zhao and Jun Zhao and Yanqiu Zhao and Xiaoyang Dai and Xiumei Dai and Mingjun Li and Yanyan Xie and Yu Yang and Yu Yao and Mingfang Zhao and Chengzhi Zhou and XIUBAO REN and Zhe Li and Zhe Liu and Yue Yin Pan and Yuping Li and Yuping Li and Baogang Liu and Ying Cheng and Ying Cheng and Liyun Miao and Yu Qian and Qitao Yu and Zhihong Zhang and Zhihong Zhang and Xiaoqing Liu and Jiuwei Cui and Jiu-Wei Cui and Z yu and Yu Zhang and Lubo Zhang and Li Zhang and Xiaoyan Li and Xiaoyan Li and Xiaoling Li and Xiaoling Li and Bo Shen and Bo Shen and Chongwen Bi and Bi Chen and Shan Zeng and Bin Li and Bin Li and Yong Hu and Yanping Hu and Lin Li and others},
title = {Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial},
journal = {Journal of Thoracic Oncology},
year = {2024},
volume = {19},
publisher = {Elsevier},
month = {feb},
url = {https://linkinghub.elsevier.com/retrieve/pii/S1556086423022591},
number = {2},
pages = {314--324},
doi = {10.1016/j.jtho.2023.09.1449}
}
Cite this
MLA
Copy
Duan, Jianchun, et al. “Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial.” Journal of Thoracic Oncology, vol. 19, no. 2, Feb. 2024, pp. 314-324. https://linkinghub.elsevier.com/retrieve/pii/S1556086423022591.
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