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T. Seto



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    First line for oncogene addicted lung cancer (ID 2)

    • Event: ELCC 2018
    • Type: Educational session
    • Track:
    • Presentations: 1
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      The role of first-line combination therapy for oncogene addicted lung cancer (ID 5)

      14:30 - 16:00  |  Presenting Author(s): T. Seto

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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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): T. Seto

      • Abstract
      • Slides

      Background:
      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.

      Methods:
      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.

      Results:
      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).

      Conclusions:
      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

      Funding:
      Has not received any funding

      Disclosure:
      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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    New approaches in rare thoracic tumors (ID 60)

    • Event: ELCC 2018
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
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      112O - Primary result of an investigator-initiated phase II trial of nivolumab for unresectable or recurrent thymic carcinoma: PRIMER study (NCCH1505) (ID 349)

      11:00 - 12:30  |  Presenting Author(s): T. Seto

      • Abstract
      • Presentation
      • Slides

      Background:
      Thymic carcinoma (TC) is a rare cancer with a poor prognosis. Treatment options are limited, especially after relapse. We previously reported that PD-L1 positivity was observed in 70% of TCs by immunohistochemistry suggesting anti PD-1/PD-L1 agents could be a promising treatment.

      Methods:
      In this open-label, two-stage, multi-center, single-arm, phase II trial, the main eligibility criteria were: unresectable or recurrent TC, an ECOG-PS of 0 or 1, the presence of measurable disease, progression after at least one previous platinum-based chemo(radio)therapy treatment, and no history of autoimmune disease. Nivolumab was administered at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the response rate (RR) as evaluated by central review using the RECIST v1.1; secondary endpoints include progression-free survival (PFS), overall survival, disease control rate, and safety. The planned sample size was 15 for the first stage and 15 for the second stage, with a threshold RR of 5%, an expected RR of 20%, one-sided alpha of 5% and power of 80%. This trial was registered with UMIN000022007.

      Results:
      Between July 1 and August 16, 2016, 15 patients were accrued in the first stage; at the data cutoff (August 31, 2017), all were assessable for a response. Median follow-up time was 3.8 months (range 1.4–12.0). All were Japanese, 12 were male, median age was 55 (range 34–70), 13 had squamous histology. The median number of nivolumab cycles received was 8 (range 3–29). RR by central review was 0% (no patient with complete or partial response; 95% confidence interval [CI]: 0–21.8). Eleven patients had stable disease and four had progressive disease. Median PFS was 3.8 months (95% CI: 1.9–5.6), and 12-month PFS rate was 13.3% (95% CI: 2.2–34.6). Two patients experienced a treatment-related serious adverse events (grade 3 AST increase and grade 2 adrenal insufficiency). Because the early termination criteria at the first stage (less than one responder) was fulfilled, the patient accrual was terminated.

      Conclusions:
      Despite of the small number of patients, our results suggested further development of nivolumab is not recommended in previously treated unresectable or recurrent TC.

      Clinical trial identification:


      Legal entity responsible for the study:
      None

      Funding:
      Japan Agency for Medical Research and Development

      Disclosure:
      T. Seto: Consulting and advisory services, speaking or writing engagements, public presentations; AstraZeneca, Bristol-Myers Squibb, Chugai, Eli Lilly, MSD, Nippon Boehringer Ingelheim, Ono, Pfizer, Taiho, Takeda. Direct research support to the responsible project lead (e.g., Principal Investigator); Eisai, MSD, Nippon Boehringer Ingelheim, AstraZeneca, Astellas, Chugai, Daiichi Sankyo, Eli Lilly, Merck Serono, Novartis, Pfizer. H. Horinouchi: Research Grant; Ono pharmaceutical, BMS, MSD, Taiho, Chugai, Novartis, Astellas, Merck Serono. Honoraria; Ono pharmaceutical, BMS, Taiho, Chugai, Novartis, Lilly, AstraZeneca. S. Umemura: Corporate-sponsored research; MSD, AstraZeneca. Honoraria; AstraZeneca, Chugai pharmaceutical, Ono, Boehringer ingelheim. Y. Hosomi: Honoraria; Lilly, Ono pharmaceutical, BMS, Chugai, AstraZeneca. Corporate-sponsored research; Lilly, Ono pharmaceutical, Chugai, AstraZeneca, Taiho, MSD. M. Satouchi: Corporate-sponsored research; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Novartis, Ono Pharmaceutical, Pfizer Japan. Lecture fees and/or honoraria; AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Merck, Novartis, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical. Y. Ohe: Corporate-sponsored research; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Kyorin, Dainippon-Sumitomo, Ignyta. Membership on an advisory board or board of directors or other substantive relationships; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Daiichi-Sankyo, Nipponkayaku, Boehringer Ingelheim, Bayer. All other authors have declared no conflicts of interest.

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