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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

 Keunchil Park  ;  Pasi A Jӓnne  ;  Dong-Wan Kim  ;  Ji-Youn Han  ;  Ming-Fang Wu  ;  Jong-Seok Lee  ;  Jin-Hyoung Kang  ;  Dae Ho Lee  ;  Byoung Chul Cho  ;  Chong-Jen Yu  ;  Yong Kek Pang  ;  Enriqueta Felip  ;  Hyunjin Kim  ;  Eunhye Baek  ;  Young Su Noh 
 CANCER, Vol.127(9) : 1407-1416, 2021-05 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Brain Neoplasms / secondary ; Carcinoma, Non-Small-Cell Lung / drug therapy* ; Carcinoma, Non-Small-Cell Lung / genetics ; Carcinoma, Non-Small-Cell Lung / mortality ; Carcinoma, Non-Small-Cell Lung / pathology ; Circulating Tumor DNA ; Confidence Intervals ; Drug Administration Schedule ; ErbB Receptors / antagonists & inhibitors ; ErbB Receptors / genetics* ; Female ; Humans ; Lung Neoplasms / drug therapy* ; Lung Neoplasms / genetics ; Lung Neoplasms / mortality ; Lung Neoplasms / pathology ; Male ; Middle Aged ; Mutation ; Piperazines / administration & dosage ; Piperazines / adverse effects ; Piperazines / therapeutic use* ; Progression-Free Survival ; Protein Kinase Inhibitors / therapeutic use ; Pyrimidines / administration & dosage ; Pyrimidines / adverse effects ; Pyrimidines / therapeutic use* ; Treatment Failure
T790M ; epidermal growth factor receptor ; non-small cell lung cancer ; olmutinib ; tyrosine kinase inhibitor
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.
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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