Park, Keunchil and Janne, Pasi A. and Kim, Dong-Wan and Han, Ji-Youn and Wu, Ming-Fang and Lee, Jong-Seok and Kang, Jin-Hyoung and Lee, Dae Ho and Cho, Byoung Chul and Yu, Chong-Jen and Pang, Yong Kek and Felip, Enriqueta and Kim, Hyunjin and Baek, Eunhye and Noh, Young Su (2021) Olmutinib in T790M-positive non-small cell lung cancer after failure of first-line epidermal growth factor receptor-tyrosine kinase inhibitor therapy: A global, phase 2 study. Cancer, 127 (9). pp. 1407-1416. ISSN 0008-543X, DOI https://doi.org/10.1002/cncr.33385.
Full text not available from this repository.Abstract
BACKGROUND: In this open-label, international phase 2 study, the authors assessed the efficacy and safety of olmutinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had a confirmed T790M mutation and disease progression on previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy. METHODS: Patients aged >= 20 years received once-daily oral olmutinib 800 mg continuously in 21-day cycles. The primary endpoint was the objective response rate (patients who had a confirmed best overall response of a complete or partial response), assessed by central review. Secondary endpoints included the disease control rate, the duration of objective response, progression-free survival, and overall survival. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). RESULTS: Overall, 162 patients (median age, 63 years; women, >60%) were enrolled from 68 sites in 9 countries. At the time of database cutoff, 23.5% of enrolled patients remained on treatment. The median treatment duration was 6.5 months (range, 0.03-21.68 months). Overall, 46.3% of patients (95% CI, 38.4%-54.3%) had a confirmed objective response (all partial responses). The best overall response (the objective response rate regardless of confirmation) was 51.9% (84 patients; 95% CI, 43.9%-59.8%). The confirmed disease control rate for all patients was 86.4% ( 95% CI, 80.2%-91.3%). The median duration of objective response was 12.7 months (95% CI, 8.3-15.4 months). Estimated median progression-free survival was 9.4 months (95% CI, 6.9-12.3 months), and estimated median overall survival was 19.7 months (95% CI, 15.1 months to not reached). All patients experienced treatment-emergent adverse events, and 71.6% of patients had grade >= 3 treatment-emergent adverse events. CONCLUSIONS: Olmutinib has meaningful clinical activity and a manageable safety profile in patients with T790M-positive non-small cell lung cancer who received previous epidermal growth factor receptor-tyrosine kinase inhibitor therapy. Cancer 2020;0:1-10. (c) 2020 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
| Item Type: | Article |
|---|---|
| Funders: | Hanmi Pharmaceutical Company, Ltd. |
| Uncontrolled Keywords: | Epidermal growth factor receptor; Non-small cell lung cancer; Olmutinib; T790M; Tyrosine kinase inhibitor |
| Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms Zaharah Ramly |
| Date Deposited: | 14 Sep 2022 00:13 |
| Last Modified: | 14 Sep 2022 00:13 |
| URI: | http://eprints.um.edu.my/id/eprint/34648 |
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