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
Open accessAbstract
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.
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Rezivertinib selectively inhibits the proliferation of EGFR mutated cells in cell lines.
“Rezivertinib selectively inhibits the proliferation of EGFR mutated cells in cell lines.142,169–171”
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Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials
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- Authors
- Shi, Y., Zhou, J., Zhao, Y., Zhu, B., Zhang, L., Li, X., Fang, J., Shi, J., Zhuang, Z., Yang, S., Wang, D., Yu, H., Zhang, L., Zheng, R., Greco, M., & Wang, T.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- First Affiliated Hospital Zhejiang University (CN)
- Zhengzhou University (CN)
- Army Medical University (CN)
- Yuhuangding Hospital (CN)
- First Affiliated Hospital of Zhengzhou University (CN)
- Peking University Cancer Hospital (CN)
- Second Affiliated Hospital of Soochow University (CN)
- Chongqing University (CN)
- First Affiliated Hospital of Bengbu Medical College (CN)
- Corresponding author
- Shi, Yuankai
- ORCID
- Venue
- BMC Medicine
- Published
- 2023-01-08
- Volume
- 21
- Issue
- 1
- Pages
- 11-11
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC9827694
- OpenAlex
- W4313788896
- Cited by
- 13
- References
- 31
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 3 · 2023: 2
- FWCI
- 2.38
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- China National Major Project for New Drug Innovation (2017ZX09304015)
- New National Natural Science Foundation of China (82172856, 81972805)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- EGFR tyrosine kinase inhibitors, EGFR mutation, non-small cell lung cancer, metastatic non-small cell lung cancer, recurrent NSCLC, locally advanced non-small cell lung cancer, first-line therapy, objective response rate, progression-free survival, treatment safety, adverse events
- MeSH terms
- Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Mutation, Protein Kinase Inhibitors, ErbB Receptors
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