Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Open accessPublished version of a preprint
Abstract
Epidermal growth factor receptor exon 20 insertion mutations (EGFRexon20ins) are detected in approximately 2% of patients with non-small cell lung cancer (NSCLC). Due to a lack of effective therapy, the prognosis of these patients is typically poor. Sunvozertinib (DZD9008) was designed as an oral, potent, irreversible, and selective EGFR tyrosine kinase inhibitor, showing activity against EGFRexon20ins and other mutations. In both cell lines and xenograft models, sunvozertinib shows potent antitumor activity. In the two ongoing phase I clinical studies, sunvozertinib was tolerated up to 400 mg once daily. The most common drug-related adverse events included diarrhea and skin rash. Antitumor efficacy was observed at the doses of 100 mg and above in patients with EGFRexon20ins NSCLC across different subtypes, with prior amivantamab treatment as well as with baseline brain metastasis. The median duration of response has not been reached. SIGNIFICANCE: We report the discovery and early clinical development of sunvozertinib, a potential treatment option for the unmet medical need of EGFRexon20ins NSCLC. This article is highlighted in the In This Issue feature, p. 1599.
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Sunvozertinib demonstrates desirable drug metabolism and pharmacokinetic (DMPK) characteristics in both preclinical and clinical settings.
“Additionally, as an oral agent, sunvozertinib demonstrates desirable drug metabolism and pharmacokinetic (DMPK) characteristics in both preclinical and clinical settings.166”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [166]
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References 25 · Cited by 133
Research works printed but not linked: 1
- [4]Moyer JD, Barbacci EG, Iwata KK, Arnold L, Boman B, Cunningham A,. Induction of apoptosis and cell cycle arrest by CP-358,774, an inhibitor of epidermal growth factor receptor tyrosine kinase. Cancer Res 1997; 57: 4838– 48. 9354447
- Authors
- Wang, M., Yang, J. C.-H., Mitchell, P. L., Fang, J., Camidge, D. R., Nian, W., Chiu, C.-H., Zhou, J., Zhao, Y., Su, W.-C., Yang, T.-Y., Zhu, V. W., Millward, M., Fan, Y., Huang, W.-T., Cheng, Y., Jiang, L., Brungs, D., Bazhenova, L., Lee, C. K., Gao, B., Xu, Y., Hsu, W.-H., Zheng, L., & Jänne, P. A.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- National Taiwan University (TW)
- Austin Hospital (AU)
- Peking University Cancer Hospital (CN)
- University of Colorado Cancer Center (US)
- Chongqing Cancer Hospital (CN)
- Taipei Veterans General Hospital (TW)
- Zhejiang University (CN)
- Zhengzhou University (CN)
- National Cheng Kung University Hospital (TW)
- Taichung Veterans General Hospital (TW)
- University of California, Irvine Medical Center (US)
- Linear Clinical Research (AU)
- Zhejiang Cancer Hospital (CN)
- Chi Mei Medical Center (TW)
- Jilin Province Tumor Hospital (CN)
- Shanghai Chest Hospital (CN)
- 18Southern Medical Day Care Centre, Wollongong, New South Wales, Australia.
- University of California San Diego (US)
- St George Hospital (AU)
- Blacktown & Mount Druitt Hospital (AU)
- National Taiwan University Hospital (TW)
- Dizal (Jiangsu) Pharmaceutical Co., Ltd. (China) (CN)
- 24Dana-Farber Cancer Institute, Boston, Massachusetts.
- Venue
- Cancer Discovery
- Published
- 2022-04-11
- Volume
- 12
- Issue
- 7
- Pages
- 1676-1689
- ISSN
- 2159-8274 (ISSN-L)
- 2159-8290
- PMC
- PMC9262839
- OpenAlex
- W4223521674
- Cited by
- 133
- References
- 25
- Citations by year
- 2026: 31 · 2025: 43 · 2024: 29 · 2023: 24 · 2022: 6
- FWCI
- 16.44
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Cancer Discovery (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- Funders
- Wuxi Municipal Bureau on Science and Technology (WX03-02B0105-062000-01)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Keywords
- sunvozertinib, EGFR exon 20 insertion, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, irreversible kinase inhibitors, amivantamab, brain metastases, antitumor efficacy, drug safety
- MeSH terms
- Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Exons, Humans, Lung Neoplasms, Mutation, Mutagenesis, Insertional, Antibodies, Bispecific, Protein Kinase Inhibitors, ErbB Receptors
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