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S. Atagi

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    Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)

    • Event: ELCC 2018
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      141PD - A prospective study of molecular testing status in the EGFR mutation positive NSCLC patients with disease progression during EGFR TKI treatment (REMEDY study) (ID 167)

      07:45 - 09:00  |  Author(s): S. Atagi

      • Abstract
      • Slides

      Although EGFR tyrosine kinase inhibitors (EGFR-TKI) provide significant clinical benefit in patients with EGFR-mutant non–small cell lung cancer (NSCLC), approximately 50–60% of the patients will acquire resistance by the T790M mutation. Osimertinib is a third generation EGFR-TKI and standard of care for patients whose tumor developed the acquired resistance by T790M mutations during the prior EGFR-TKI treatments. Eligibility for treatment with osimertinib will be dependent on mutation status determined by a validated diagnostic test based on a tumor tissue or a plasma. In order to avoid the risk of false negative, the Japan Lung Cancer Society's guidance on the EGFR mutation test recommends prioritizing tissue sample over plasma sample. Moreover, in case of T790M negative by prior plasma test, it also recommends to re-confirm by tissue test if it can be obtained. We conducted this study to investigate the real world practice of sample collection and T790M testing around the time of plasma testing approval in Japan.

      This is multicenter collaborative prospective observational study in Japan. Patients diagnosed with EGFR mutation-positive advanced NSCLC and whose progression of the disease (PD) was observed during EGFR-TKI treatment were enrolled. The primary endpoints are 1. the sample collection rate for EGFR T790M mutation test at PD, 2. EGFR T790M gene mutation testing and 3. the EGFR T790M detection rate. In addition, treatment information before and after PD were investigated.

      In previously reported interim analysis of 111 patients, sample collection was performed in 104 cases (93.7%). Regarding collected sample type, tissue sample were collected from 19 patients, cytology sample from 14 patients and plasma sample from 71 patients. EGFR T790M mutation test was conducted in 103 cases (92.8%). T790M mutation detection rate in patients who were obtained adequate tissue sample were 43.8% (7/16) and higher than cytology (21.4%; 3/14) and plasma (22.5%; 16/71). Sixty-one percent (43/71) of the patients tested by plasma were ctDNA “non-shedders” (no detectable EGFR mutation).

      In this presentation, we report final full results of total 243 registered cases.

      Clinical trial identification:
      UMIN ID; 000024928

      Legal entity responsible for the study:
      This study was conducted by AstraZeneca KK

      Has not received any funding

      N. Yamamoto: Personal fees from AstraZeneca, during the conduct of the study; personal fees from Chugai Pharmaceutical, Boehringer Ingelheim, Eli Lilly, and Pfizer, outside the submitted work. N. Nogami: Personal fees from Meiji Seika Pharama., AstraZeneca KK, Pfizer Inc., Bristor-Myers Squibb, ONO Pharmaceutical Co., Ltd, Kyowa Hakko Kirin, TAIHO Pharmaceutical Co., Ltd, CHUGAI Pharmaceutical Co., Ltd, Eliy Lilly Japan and Boehringer Ingelheim. S. Atagi: Personal fees from AstraZeneca KK, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Lilly, Ono and Taiho and contract research with AstraZeneca KK, Boehringer Ingelheim, Chugai, Lilly, Merck Serono, Ono, Pfizer, Taiho and Yakult and consultant fee from AstraZeneca KK. H. Saka: Personal fees from AstraZeneca KK and contract research with AstraZeneca KK. and is a representative of NPO Central Japan Lung Study Group. N. Tashiro: Employee of AstraZeneca KK. T. Seto: Grants(G): Astellas, Bayer, Merck Serono, Novartis, Verastem. Personal fees(PF): BMS, Kissei, Kyowa Hakko Kirin, Nippon Kayaku, Ono, Roche, Sanofi, Showa, Sumitomo Dainippon, Taiho, Takeda and other 3. G and PF: AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, MSD, BI, Pfizer, Yakult. All other authors have declared no conflicts of interest.

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