Safety and activity of WX-0593 (Iruplinalkib) in patients with ALK- or ROS1-rearranged advanced non-small cell lung cancer: a phase 1 dose-escalation and dose-expansion trial
WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-esc...
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| Published in | Signal transduction and targeted therapy Vol. 7; no. 1; pp. 25 - 10 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
Nature Publishing Group UK
28.01.2022
Nature Publishing Group |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2059-3635 2095-9907 2059-3635 |
| DOI | 10.1038/s41392-021-00841-8 |
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| Abstract | WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with
ALK
or
ROS1
rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were
ALK
-rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were
ROS1
-rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with
ALK
or
ROS1
rearrangement. |
|---|---|
| AbstractList | Abstract WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were ALK-rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were ROS1-rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with ALK or ROS1 rearrangement. WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were ALK -rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were ROS1 -rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with ALK or ROS1 rearrangement. WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were ALK-rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were ROS1-rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with ALK or ROS1 rearrangement.WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were ALK-rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were ROS1-rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with ALK or ROS1 rearrangement. WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and pharmacokinetics of WX-0593 were evaluated in advanced non-small cell lung cancer (NSCLC) patients with ALK or ROS1 rearrangement. In the dose-escalation phase and dose-expansion phase, patients were treated with WX-0593 until disease progression, unacceptable toxicity, or subject withdrawal. In the dose-escalation phase, the primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety assessed by investigators. In the dose-expansion phase, the primary endpoint was objective response rate (ORR) assessed by investigators. Between September 25, 2017 and October 15, 2018, a total of 153 patients received WX-0593 treatment. Two dose-limiting toxicities (DLTs) including one grade 3 QT interval prolonged and one grade 2 chronic heart failure were reported at the dose of 300 mg in one patient. MTD was not reached. Overall, 140 of the 152 (92%) patients experienced treatment-related adverse events (TRAEs) and 35 of the 152 (23%) patients had TRAEs ≥grade 3. The overall ORR was 59.3% (32 of 54) for the dose-escalation phase and 56.6% (56 of 99) for the dose-expansion phase. For patients who were ALK-rearranged and ALK TKI naive, the ORR were 81.0% (17 of 21) in the dose-escalation phase and 76.3% (29 of 38) in the dose-expansion phase, and for patients who previously received crizotinib as the only ALK TKI, the ORR were 38.1% (8 of 21) and 45.7% (21 of 46) for the two phases, respectively. For patients who were ROS1-rearranged, the ORR were 30.0% (3 of 10) in the dose-escalation phase and 44.4% (4 of 9) in the dose-expansion phase. WX-0593 showed favorable safety and promising antitumor activity in advanced NSCLC patients with ALK or ROS1 rearrangement. |
| ArticleNumber | 25 |
| Author | Gu, Kangsheng Ouyang, Weiwei Liu, Yunpeng Zhang, Liangming Zhao, Yanqiu Shi, Yuankai Hang, Xiaosheng Lu, Pei Zhang, Helong Liu, Chunling Zhao, Jun Huang, Jian’an Zhang, Shucai Hao, Xuezhi Wang, Zhehai Geng, Huaize Si, Meimei Hu, Yanping Chen, Jianhua Li, Juan Hu, Yi Zhang, Yiping Fang, Jian Li, Weidong Ge, Mingjing Wang, Lin Yu, Yan Zhuang, Wu Shan, Jinlu |
| Author_xml | – sequence: 1 givenname: Yuankai orcidid: 0000-0002-3342-4964 surname: Shi fullname: Shi, Yuankai email: syuankai@cicams.ac.cn organization: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs – sequence: 2 givenname: Jian surname: Fang fullname: Fang, Jian organization: Beijing Cancer Hospital – sequence: 3 givenname: Xuezhi surname: Hao fullname: Hao, Xuezhi organization: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs – sequence: 4 givenname: Shucai surname: Zhang fullname: Zhang, Shucai organization: Beijing Chest Hospital, Capital Medical University – sequence: 5 givenname: Yunpeng surname: Liu fullname: Liu, Yunpeng organization: The First Hospital of China Medical University – sequence: 6 givenname: Lin surname: Wang fullname: Wang, Lin organization: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs – sequence: 7 givenname: Jianhua surname: Chen fullname: Chen, Jianhua organization: Hunan Cancer Hospital – sequence: 8 givenname: Yi surname: Hu fullname: Hu, Yi organization: Chinese PLA General Hospital – sequence: 9 givenname: Xiaosheng surname: Hang fullname: Hang, Xiaosheng organization: Affiliated Hospital of Jiangnan University – sequence: 10 givenname: Juan surname: Li fullname: Li, Juan organization: Sichuan Cancer Hospital – sequence: 11 givenname: Chunling surname: Liu fullname: Liu, Chunling organization: Affiliated Tumour Hospital of Xinjiang Medical University – sequence: 12 givenname: Yiping surname: Zhang fullname: Zhang, Yiping organization: Zhejiang Cancer Hospital – sequence: 13 givenname: Zhehai surname: Wang fullname: Wang, Zhehai organization: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences – sequence: 14 givenname: Yanping surname: Hu fullname: Hu, Yanping organization: Hubei Cancer Hospital – sequence: 15 givenname: Kangsheng surname: Gu fullname: Gu, Kangsheng organization: The First Affiliated Hospital of Anhui Medical University – sequence: 16 givenname: Jian’an surname: Huang fullname: Huang, Jian’an organization: The First Affiliated Hospital of Soochow University – sequence: 17 givenname: Liangming surname: Zhang fullname: Zhang, Liangming organization: Yantai Yuhuagding Hospital – sequence: 18 givenname: Jinlu surname: Shan fullname: Shan, Jinlu organization: Army Medical Center of People’s Liberation Army – sequence: 19 givenname: Weiwei surname: Ouyang fullname: Ouyang, Weiwei organization: Guizhou Cancer Hospital – sequence: 20 givenname: Yanqiu surname: Zhao fullname: Zhao, Yanqiu organization: Henan Cancer Hospital – sequence: 21 givenname: Wu surname: Zhuang fullname: Zhuang, Wu organization: Fujian Province Cancer Hospital – sequence: 22 givenname: Yan surname: Yu fullname: Yu, Yan organization: Harbin Medical University Cancer Hospital – sequence: 23 givenname: Jun surname: Zhao fullname: Zhao, Jun organization: Beijing Cancer Hospital – sequence: 24 givenname: Helong surname: Zhang fullname: Zhang, Helong organization: Tangdu Hospital of the Fourth Military Medical University – sequence: 25 givenname: Pei surname: Lu fullname: Lu, Pei organization: Liuzhou People’s Hospital – sequence: 26 givenname: Weidong surname: Li fullname: Li, Weidong organization: Cancer Center of Guangzhou Medical University – sequence: 27 givenname: Meimei surname: Si fullname: Si, Meimei organization: Qilu Pharmaceutical Co., Ltd – sequence: 28 givenname: Mingjing surname: Ge fullname: Ge, Mingjing organization: Qilu Pharmaceutical Co., Ltd – sequence: 29 givenname: Huaize surname: Geng fullname: Geng, Huaize organization: Qilu Pharmaceutical Co., Ltd |
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| Snippet | WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity, and... Abstract WX-0593 (Iruplinalkib) is a novel, highly selective oral ALK and ROS1 tyrosine kinase inhibitor (TKI). In this study, the safety, antitumor activity,... |
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| SubjectTerms | 631/67/1612 692/4028/67/1612 Adult Aged Anaplastic Lymphoma Kinase - genetics Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antitumor activity Cancer Research Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - enzymology Carcinoma, Non-Small-Cell Lung - genetics Cell Biology Congestive heart failure Enzyme inhibitors Female Follow-Up Studies Gene Rearrangement Humans Inhibitor drugs Internal Medicine Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - enzymology Lung Neoplasms - genetics Male Medicine Medicine & Public Health Middle Aged Non-small cell lung carcinoma Oncology Pathology Patients Pharmacokinetics Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Protein-tyrosine kinase Protein-Tyrosine Kinases - genetics Proto-Oncogene Proteins - genetics Safety Small cell lung carcinoma Toxicity |
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| Title | Safety and activity of WX-0593 (Iruplinalkib) in patients with ALK- or ROS1-rearranged advanced non-small cell lung cancer: a phase 1 dose-escalation and dose-expansion trial |
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