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Epidermal growth factor receptor (  EGFR  ) activating mutations occur in approximately 50% of East Asian patients with non‐small‐cell lung cancer ( NSCLC ) and confer sensitivity to tyrosine kinase inhibitors ( TKI s).  ASP 8273 is an irreversible  EGFR ‐ TKI , given orally, that inhibits   EGFR   activating mutations and has shown clinical activity in patients with   EGFR   mutation‐positive  NSCLC . Epidermal growth factor receptor‐ TKI ‐naïve Japanese adult patients (≥20 years) with  NSCLC  harboring   EGFR   mutations were enrolled in this open‐label, single‐arm, phase  II  study (ClinicalTrials.gov identifier  NCT 02500927). Patients received  ASP 8273 300 mg once daily until discontinuation criteria were met. The primary end‐point was to determine the safety of  ASP 8273 300 mg; the secondary end‐point was antitumor activity defined by  RECIST  version 1.1. Thirty‐one patients (12 men and 19 women; median age, 64 years [range, 31‐82 years]) with   EGFR   mutation‐positive  NSCLC  were enrolled; as of 23 February 2016, 25 patients (81%) were still on study. Of the 31 patients, 27 (87%) had an exon 19 deletion (n = 13, 42%) or an L858R (n = 14, 45%)   EGFR   activating mutation, and two (7%) had an L861Q mutation. Five patients (16%) had other   EGFR   activating mutations, two had an activating mutation and the T790M resistance mutation. The most commonly reported treatment‐emergent adverse event was diarrhea (n = 24, 77%). All patients had at least one post‐baseline scan; one patient (3%) achieved a confirmed complete response, 13 (42%) had a confirmed partial response, and 15 (48%) had confirmed stable disease (disease control rate, 94% [n = 29/31]) per investigator assessment. Once‐daily  ASP 8273 at 300 mg was generally well tolerated and showed antitumor activity in  TKI ‐naïve Japanese patients with   EGFR   mutation‐positive  NSCLC .

cancer science

ASP 8273 tolerability and antitumor activity in tyrosine kinase inhibitor‐naïve Japanese patients with   EGFR   mutation‐positive non‐small‐cell lung cancer