A phase II study (WJOG12819L) to assess the efficacy of osimertinib in patients with EGFR mutation-positive NSCLC in whom systemic disease (T790M-negative) progressed after treatment with first- or second-generation EGFR TKIs and platinum-based chemotherapy

Masayuki Takeda, Mototsugu Shimokawa, Atsushi Nakamura, Kaname Nosaki, Yasutaka Watanabe, Terufumi Kato, Daisuke Hayakawa, Hiroshi Tanaka, Toshiaki Takahashi, Masahide Oki, Motoko Tachihara, Daichi Fujimoto, Hidetoshi Hayashi, Kakuhiro Yamaguchi, Shoichiro Yamamoto, Eiji Iwama, Koichi Azuma, Kazuo Hasegawa, Nobuyuki Yamamoto, Kazuhiko Nakagawa

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    4 Citations (Scopus)

    Abstract

    Background: Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is an established standard treatment option for chemotherapy-naive patients with EGFR mutation-positive non–small cell lung cancer (NSCLC). However, of such patients who have received prior treatment with a first- or second-generation EGFR TKI, only approximately half are eligible for osimertinib therapy because its indication as second-line treatment and beyond is limited to metastatic NSCLC that is positive for the T790M resistance mutation of the EGFR gene. This study was initiated at the request of a dedicated network for patients with lung cancer in Japan. Methods: We conducted a phase II study to assess the efficacy of osimertinib in patients with EGFR mutation-positive NSCLC in whom systemic disease (T790M-negative) progressed after treatment with first- or second-generation EGFR TKIs and platinum-based chemotherapy. The primary end point was response rate (assessed by a central imaging reviewer). Results: From August 2020 to February 2021, 55 patients from 15 institutions were enrolled in the study. The overall response for primary analysis was achieved in 16 patients (29.1 %; 95 % CI, 17.6–42.9), which exceeded the threshold response rate necessary for analysis. Stable disease was found in 16 patients (29.1 %), and progressive disease, in 18 (32.7 %). The median length of progression-free survival (PFS) was 4.07 months (95 % CI 2.10–4.30), and the rate of 12-month PFS was 17.3 %. Conclusions: Osimertinib demonstrated modest antitumor activity against progressive EGFR T790M-negative disease.

    Original languageEnglish
    Pages (from-to)44-50
    Number of pages7
    JournalLung Cancer
    Volume177
    DOIs
    Publication statusPublished - Mar 2023

    All Science Journal Classification (ASJC) codes

    • Oncology
    • Pulmonary and Respiratory Medicine
    • Cancer Research

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