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- Title
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.
- Authors
Park, Keunchil; Jӓnne, Pasi A.; Kim, Dong‐Wan; Han, Ji‐Youn; Wu, Ming‐Fang; Lee, Jong‐Seok; Kang, Jin‐Hyoung; Lee, Dae Ho; Cho, Byoung Chul; Yu, Chong‐Jen; Pang, Yong Kek; Felip, Enriqueta; Kim, Hyunjin; Baek, Eunhye; Noh, Young Su; Kim, Dong-Wan; Han, Ji-Youn; Wu, Ming-Fang; Lee, Jong-Seok; Kang, Jin-Hyoung
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
NATIONAL Cancer Institute (U.S.); NON-small-cell lung carcinoma; EPIDERMAL growth factor; ERLOTINIB; ANAPLASTIC lymphoma kinase; EPIDERMAL growth factor receptors; KINASE inhibitors; PROTEIN-tyrosine kinases; NON-communicable diseases; LUNG cancer; RESEARCH; CONFIDENCE intervals; GENETIC mutation; HETEROCYCLIC compounds; PROTEIN kinase inhibitors; RESEARCH methodology; LUNG tumors; CELL receptors; MEDICAL cooperation; EVALUATION research; TREATMENT failure; BRAIN tumors; DRUG administration; COMPARATIVE studies; RESEARCH funding
- Publication
Cancer (0008543X), 2021, Vol 127, Issue 9, p1407
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.33385