Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study
Abstract Background Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This phase IIa study was part of a phase I/IIa study (NCT03386955), aimed to evaluate the efficacy and safety of rezivertinib as the first-line treatment f...
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| Language: | English |
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BMC
2023-01-01
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| Series: | BMC Medicine |
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| Online Access: | https://doi.org/10.1186/s12916-022-02692-8 |
| _version_ | 1828063671077568512 |
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| author | Yuankai Shi Jianying Zhou Yanqiu Zhao Bo Zhu Liangming Zhang Xingya Li Jian Fang Jianhua Shi Zhixiang Zhuang Sheng Yang Donglin Wang Huiqing Yu Longzhen Zhang Rongsheng Zheng Michael Greco Tingting Wang |
| author_facet | Yuankai Shi Jianying Zhou Yanqiu Zhao Bo Zhu Liangming Zhang Xingya Li Jian Fang Jianhua Shi Zhixiang Zhuang Sheng Yang Donglin Wang Huiqing Yu Longzhen Zhang Rongsheng Zheng Michael Greco Tingting Wang |
| author_sort | Yuankai Shi |
| collection | DOAJ |
| description | Abstract Background Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This phase IIa study was part of a phase I/IIa study (NCT03386955), aimed to evaluate the efficacy and safety of rezivertinib as the first-line treatment for patients with locally advanced or metastatic/recurrent EGFR mutated non-small cell lung cancer (NSCLC). Methods Patients received the first-line treatment of 180 mg rezivertinib orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Results From Jun 12, 2019, to Oct 17, 2019, 43 patients were enrolled. At the data cutoff date on Dec 23, 2021, the ORR by BICR was 83.7% (95% CI: 69.3–93.2%). The median DoR was 19.3 (95% CI: 15.8–25.0) months. The median PFS by BICR was 20.7 (95% CI: 13.8–24.8) months and 22.0 (95% CI: 16.8–26.3) months by investigators. Data on OS was immature. Totally, 40 (93.0%) patients had at least one treatment-related adverse event while 4 (9.3%) of them were grade ≥ 3. Conclusions Rezivertinib (BPI-7711) showed promising efficacy and a favorable safety profile for the treatment among the locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation in the first-line setting. Trial registration ClinicalTrials.gov, NCT03386955. |
| first_indexed | 2024-04-10T22:46:44Z |
| format | Article |
| id | doaj.art-1a68837f5b334a76b6788911530e9531 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-04-10T22:46:44Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
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| series | BMC Medicine |
| spelling | doaj.art-1a68837f5b334a76b6788911530e95312023-01-15T12:14:02ZengBMCBMC Medicine1741-70152023-01-0121111310.1186/s12916-022-02692-8Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa studyYuankai Shi0Jianying Zhou1Yanqiu Zhao2Bo Zhu3Liangming Zhang4Xingya Li5Jian Fang6Jianhua Shi7Zhixiang Zhuang8Sheng Yang9Donglin Wang10Huiqing Yu11Longzhen Zhang12Rongsheng Zheng13Michael Greco14Tingting Wang15Department of Medical Oncology, 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 DrugsDepartment of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, School of MedicineDepartment of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou UniversityDepartment of Oncology, Institute of Cancer, Xinqiao Hospital, Third Military Medical UniversityDepartment of Medical Oncology, Yantai Yuhuangding HospitalDepartment of Oncology, The First Affiliated Hospital of Zhengzhou UniversityDepartment of Thoracic Oncology, Beijing Cancer HospitalDepartment of Medical Oncology, Linyi Cancer HospitalDepartment of Oncology, The Second Affiliated Hospital of Soochow UniversityDepartment of Medical Oncology, 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 DrugsDepartment of Medical Oncology, Chongqing University Cancer HospitalDepartment of Palliative Care, Department of Geriatric Oncology, Chongqing University Cancer HospitalDepartment of Radiotherapy, The Affiliated Hospital of Xuzhou Medical UniversityDepartment of Medical Oncology, The First Affiliated Hospital of Bengbu Medical CollegeDepartment of Drug Discovery, Beta Pharma Inc.Department of Clinical Development, Beta Pharma (Shanghai) Co., LtdAbstract Background Rezivertinib (BPI-7711) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This phase IIa study was part of a phase I/IIa study (NCT03386955), aimed to evaluate the efficacy and safety of rezivertinib as the first-line treatment for patients with locally advanced or metastatic/recurrent EGFR mutated non-small cell lung cancer (NSCLC). Methods Patients received the first-line treatment of 180 mg rezivertinib orally once daily until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Results From Jun 12, 2019, to Oct 17, 2019, 43 patients were enrolled. At the data cutoff date on Dec 23, 2021, the ORR by BICR was 83.7% (95% CI: 69.3–93.2%). The median DoR was 19.3 (95% CI: 15.8–25.0) months. The median PFS by BICR was 20.7 (95% CI: 13.8–24.8) months and 22.0 (95% CI: 16.8–26.3) months by investigators. Data on OS was immature. Totally, 40 (93.0%) patients had at least one treatment-related adverse event while 4 (9.3%) of them were grade ≥ 3. Conclusions Rezivertinib (BPI-7711) showed promising efficacy and a favorable safety profile for the treatment among the locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation in the first-line setting. Trial registration ClinicalTrials.gov, NCT03386955.https://doi.org/10.1186/s12916-022-02692-8RezivertinibBPI-7711NSCLCEGFR mutationThird-generation EGFR TKI |
| spellingShingle | Yuankai Shi Jianying Zhou Yanqiu Zhao Bo Zhu Liangming Zhang Xingya Li Jian Fang Jianhua Shi Zhixiang Zhuang Sheng Yang Donglin Wang Huiqing Yu Longzhen Zhang Rongsheng Zheng Michael Greco Tingting Wang Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study BMC Medicine Rezivertinib BPI-7711 NSCLC EGFR mutation Third-generation EGFR TKI |
| title | Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study |
| title_full | Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study |
| title_fullStr | Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study |
| title_full_unstemmed | Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study |
| title_short | Results of the phase IIa study to evaluate the efficacy and safety of rezivertinib (BPI-7711) for the first-line treatment of locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation from a phase I/IIa study |
| title_sort | results of the phase iia study to evaluate the efficacy and safety of rezivertinib bpi 7711 for the first line treatment of locally advanced or metastatic recurrent nsclc patients with egfr mutation from a phase i iia study |
| topic | Rezivertinib BPI-7711 NSCLC EGFR mutation Third-generation EGFR TKI |
| url | https://doi.org/10.1186/s12916-022-02692-8 |
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