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K. Ohashi



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    MA 07 - ALK, ROS and HER2 (ID 673)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA 07.11 - A Phase II Study of Trastuzumab Emtansine in HER2-positive Non-Small-Cell-Lung Cancer (ID 8453)

      16:55 - 17:00  |  Author(s): K. Ohashi

      • Abstract
      • Presentation
      • Slides

      Background:
      Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with vinca-alkaloid, has been approved for clinical use in HER2-positive breast cancer. HER2-alterations are detected even in non-small-cell lung cancer (NSCLC). We have launched a phase II trial of T-DM1 monotherapy for patients with HER2-positive lung cancer.

      Method:
      Eligible patients had pathologically diagnosed NSCLC with documented HER2-positivity (immunohistochemistry [IHC] 3+, both IHC 2+ and fluorescence in situ hybridization [FISH] +, or exon 20 insertion mutation) and were previously treated with standard chemotherapy. Thirty patients would receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate (ORR) per RECIST v1.1.

      Result:
      This study was early terminated due to the limited efficacy, leading that only 16 patients were registered. The demographics of the 15 evaluable patients were as follows: age (median; 67, range: 45-77), sex (male; 47%), performance status (0-1; 80%), histology (non-squamous; 100%), HER2 status (IHC3+; 33%, IHC2+/FISH; 20%, and mutation; 47%) and number of prior chemotherapeutic regimens (median; 4, range: 1-7). Of 15 patients, one, who possessed HER2 mutation achieved a partial response, resulting in ORR of 6.7%. None of the 15 patients experienced treatment-related deaths. Survival data would be presented at the meeting.

      Conclusion:
      T-DM1 has a limited efficacy for HER2-positive NSCLCs in our cohort. Additional molecular approaches are warranted for the precision medicine in HER2-positive tumors. UMIN registration number 000019446.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.01-088k - Significance of Second Rebiopsy for Detecting T790M Mutation (ID 8642)

      09:30 - 09:30  |  Author(s): K. Ohashi

      • Abstract

      Background:
      Osimertinib is an essential drug for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) T790M mutation and rebiopsy is recommended for detecting T790M. However, significance of repeating rebiopsy in NSCLCs that were T790M negative with first rebiopsy remains unclear. Here, we sought to clarify this issue using a retrospective cohort.

      Method:
      We reviewed the medical records of patients with consecutive advanced NSCLC harboring activating EGFR mutations who underwent EGFR tyrosine kinase inhibitor (TKI) at Okayama University Hospital between Jan 2015 and Jan 2017.

      Result:
      In total, 104 patients were included in this study, and 47 patients underwent rebiopsy after acquiring resistance to prior EGFR TKIs. Preexisting activating EGFR mutations were found in all the 47 rebiopsied samples. Nineteen of them were T790M positive (40%). In the remaining 28 patients (T790M negative with first rebiopsy), 18 patients underwent additional rebiopsies following to interval therapies. Eleven (61%) of them were T790M positive with 2nd/3rd rebiopsy (10 with 2nd rebiopsy and 1 with 3rd rebiopsy). In majority of the 11 patients, rebiopsied samples were obtained from different lesions between first and 2nd/3rd rebiopsy (8/11, 73%). We also evaluated the efficacy of osimertinib in the 11 patients who needed 2nd/3rd rebiopsy for detecting T790M. Osimertinib showed good activity with the objective response rate 56% and the median progression free survival 5.5 months (95% confidence interval 4.1-6.9), though it is worse compared to with historical control osimertinib therapy.

      Conclusion:
      T790M could be found even in T790M negative NSCLCs with first rebiospy. Data will be updated at the meeting.