Evidence map›Paper›PMID 36617560›Full record

Trial reportBMC medicine2023

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.

Yuankai Shi, Jianying Zhou, Yanqiu Zhao, Bo Zhu, Liangming Zhang, Xingya Li, Jian Fang, Jianhua Shi, Zhixiang Zhuang, Sheng Yang and 6 more

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

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03386955 (An Open-label, Single Arm, Phase I/IIa Study to Evaluate Safety, Dose Escalation Tolerability, Pharmacokinetics and Antineoplastic Activity of the BPI-7711 Capsule in Patients With EGFR Mutation Advanced or Recurrent NSCLC), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03386955 phase1 / phase2completednot on this map

An Open-label, Single Arm, Phase I/IIa Study to Evaluate Safety, Dose Escalation Tolerability, Pharmacokinetics and Antineoplastic Activity of the BPI-7711 Capsule in Patients With EGFR Mutation Advanced or Recurrent NSCLC

TypeinterventionalSponsorBeta Pharma ShanghaiRan2017 to 2021Enrolled215ConditionsNon-small Cell Lung CancerArmsBPI-7711 Capsule
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Rezivertinib inCancer communications (London, England) · 2026
    Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Therapeutic advances of targeting receptor tyrosine kinases in cancer.Signal transduction and targeted therapy · 2024
    Review
  7. Article
  8. 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

16 authors.

Yuankai ShiDepartment 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 Drugs, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China. syuankai@cicams.ac.cn.ORCID 0000-0002-8685-6744
Jianying ZhouDepartment of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, China.
Yanqiu ZhaoDepartment of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
Bo ZhuDepartment of Oncology, Institute of Cancer, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Liangming ZhangDepartment of Medical Oncology, Yantai Yuhuangding Hospital, Yantai, China.
Xingya LiDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Jian FangDepartment of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China.
Jianhua ShiDepartment of Medical Oncology, Linyi Cancer Hospital, Linyi, China.
Zhixiang ZhuangDepartment of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Sheng YangDepartment 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 Drugs, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.
Donglin WangDepartment of Medical Oncology, Chongqing University Cancer Hospital, Chongqing, China.
Huiqing YuDepartment of Palliative Care, Department of Geriatric Oncology, Chongqing University Cancer Hospital, Chongqing, China.
Longzhen ZhangDepartment of Radiotherapy, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Rongsheng ZhengDepartment of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Michael GrecoDepartment of Drug Discovery, Beta Pharma Inc., Princeton, NJ, USA.
Tingting WangDepartment of Clinical Development, Beta Pharma (Shanghai) Co., Ltd, Shanghai, China.

Funding

China National Major Project for New Drug Innovation 2017ZX09304015New National Natural Science Foundation of China 81972805New National Natural Science Foundation of China 82172856
6 · The paper itself

Abstract

backgroundRezivertinib (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).

methodsPatients 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.

resultsFrom 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.

conclusionsRezivertinib (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 registrationClinicalTrials.gov, NCT03386955.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsErbB ReceptorsHumansMutationProtein Kinase InhibitorsAntineoplastic AgentsEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsBPI-7711EGFR mutationNSCLCRezivertinibThird-generation EGFR TKI

Identifiers

PMID36617560
PMCPMC9827694

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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.