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S. Morita



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    OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA23.06 - Overall Survival (OS) of EGFR Mutation Positive Non-Small Cell Lung Cancer Patients: Real-World Treatment Patterns of 1,660 Japanese Patients (ID 5915)

      14:20 - 15:50  |  Author(s): S. Morita

      • Abstract
      • Presentation
      • Slides

      Background:
      Since the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) was launched in Japan, the survival periods of advanced/recurrent EGFR mutation positive (EGFR m+) non-small cell lung cancer (NSCLC) patients have been getting longer. However, clinical factors which contributed to the extension of survival periods of these patients remain unclear. We investigated overall survival, prognostic factors and treatments patterns of EGFR m+ NSCLC patients in real-world clinical practice.

      Methods:
      This is a multi-center, observational, retrospective study. Histologically or cytologically diagnosed EGFR m+ NSCLC patients who were started first-line treatment from 1/1/2008 to 31/12/2012 were enrolled. The primary objective was the estimated OS. The secondary objectives were to determine prognostic factors, real-world treatment patterns.

      Results:
      1,660 EGFR m+ NSCLC patients were enrolled from 17 hospitals in Japan (median age 67.0 years, female 64.8%, 38.9% had smoking history, ECOG-performance status 0, 1, 2, 3, 4 were 39.5%, 41.1%, 7.1%, 4.9%, 0.7%, respectively, adenocarcinoma 95.2%, 50.1% exon 19 deletion, 66.7% at stage IV). Median estimated OS was 29.7 months. Cox regression analysis revealed age, smoking history, performance status, histological diagnosis, EGFR mutation type and clinical stage were independently associated with OS. Five year survival rate of stage IV patients was 13.8%. The median number of treatment regimens was two. EGFR-TKI and platinum-doublet chemotherapy were most frequently used as first- and second-line treatments.

      Conclusion:
      Real world treatment of the large data-set of 1,660 EGFR m+ NSCLC patients was retrospectively investigated. Median OS was 29.7 months and EGFR-TKIs are major components of the treatment regimens for these patients in Japan. (NCT0247520)

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.02b-073 - A Phase II, Liquid Biopsy Study Using Digital PCR in EGFR Mutated, Lung Cancer Patients Treated with Afatinib (WJOG 8114LTR) (ID 4754)

      14:30 - 15:45  |  Author(s): S. Morita

      • Abstract

      Background:
      Liquid biopsy is an ideal strategy to monitor mutation status of cancer repeatedly and less invasively. In chronic myeloid leukemia, early remission of mutated cells was reported as a surrogate of longer efficacy. In epidermal growth factor (EGFR) mutated non-small cell lung cancer (NSCLC), to detect resistant mutation (exon20 T790M) during treatment is clinically important because newer tyrosine kinase inhibitors (TKIs) have been developed. Although some reports have mentioned the utility of liquid biopsy in EGFR mutated NSCLC, most were single-institutional, retrospective studies.

      Methods:
      West Japan Oncology Group (WJOG) 8114LTR is a multi-institutional, prospective liquid biopsy study in advanced NSCLC. Chemotherapy naïve, advanced NSCLC patients with EGFR-sensitizing mutation will receive afatinib monotherapy (40 mg/body) until progressive disease (PD) or unacceptable toxicity. Plasma DNA will be obtained from patients at baseline, 2, 4, 8, 12, 24, 48 weeks, and at PD. Three types of common EGFR mutations (exon 19 deletion, exon 20 T790M and exon 21 L858R) will be analyzed using plasma DNA with multiplexed, pico-droplet digital PCR assay (RainDrop® system, RainDance Technologies, Billerica, MA). Primary endpoint of this study is the concordance of EGFR mutation status between tissue and plasma at baseline. Secondary endpoints are overall response rate, progression-free survival and safety. This is the first report on the primary endpoint and early remission rate based on mutated cf-DNA. This study was registered at UMIN (ID: 000015847).

      Results:
      Fifty-seven patients were registered and samples from 55 patients were analyzed. Clinical characteristics were as follows; median age: 69 years, male / female: 25/30, PS 0/1: 23/32, c-stage III / IV / post-operative relapse: 2/37/16, exon 19 deletion / exon 21 L858R: 28/27. Sensitivity of plasma sample was 63.6% among overall, while that was 84.6% in patients with distant metastasis. Eighty-two percent of plasma positive patients at baseline showed molecular response in plasma after two weeks of afatinib treatment. De novo T790M mutation was detected in one patient (2%) from plasma samples.

      Conclusion:
      Liquid biopsy seemed to be suitable especially in patients with distant metastasis. Early molecular remission (within two weeks) was observed in 70% of patients.

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      P3.02b-086 - ASP8273 Tolerability and Antitumor Activity in TKI-Naïve Japanese Subjects with EGFRmut+ NSCLC: Preliminary Results (ID 4126)

      14:30 - 15:45  |  Author(s): S. Morita

      • Abstract

      Background:
      ASP8273, an orally administered epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits EGFR-activating mutations, has demonstrated clinical activity in ongoing Phase 1/2 studies in subjects with EGFR mutation-positive non-small cell lung cancer (NSCLC).

      Methods:
      EGFR TKI-naïve adult subjects (≥20 years) with EGFR mutation-positive metastatic or advanced unresectable NSCLC were enrolled in this ongoing, open-label, Phase 2 single-arm study conducted in Japan (NCT02500927). Subjects received once-daily ASP8273 300 mg until discontinuation criteria were met. The primary endpoint was tolerability; the secondary endpoint was antitumor activity (defined by RECIST v1.1).

      Results:
      As of 23 February 2016, 31 subjects (12M/19F; median age 64 years [range: 31–82]) with EGFR mutation-positive NSCLC have been enrolled; 25 subjects (81%) were still on study. Based on local testing, 27 (87%) of the 31 enrolled subjects had an ex19del (n=13, 42%) or a L858R (n=14, 45%) EGFR activating mutation; 4 subjects (13%) had other EGFR activating mutations, including 2 subjects (6%) with L861Q. Moreover, 3 subjects (10%) were found to have both an activating mutation as well as the T790M resistance mutation. Tolerability of ASP8273 is presented in Table 1; gastrointestinal disorders were the most commonly reported treatment-emergent adverse events (eg, diarrhea [n=24, 77%], nausea [n=12, 39%], and vomiting [n=8, 26%)]). All subjects had at least 1 post-baseline scan; 1 subject (3%) achieved a confirmed complete response, 13 subjects (42%) had a confirmed partial response, and 15 subjects (48%) had confirmed stable disease (disease control rate: 94% [n=29/31]) per investigator assessment. Figure 1



      Conclusion:
      These preliminary data showed that ASP8273 300 mg is generally well tolerated and demonstrates antitumor activity in TKI-naïve Japanese subjects with EGFR mutation-positive NSCLC.