Author of

• 16831

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  P1.06 - Poster Session with Presenters Present (ID 458)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 16874

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    P1.06-043 - A Study to Select Rational Therapeutics in Subjects with Advanced Malignancies (WINTHER) - The Sheba Experience in Lung Cancer Patients (ID 6414)

    14:30 - 14:30  |  Author(s): S. Halperin
    • Abstract

    Background:
    Patient-tailored therapy based on tumor genomics is a promising tool in cancer therapy. However, in current practice it is limited to 30-40% of the patients whose tumor harbor actionable DNA mutations or amplifications
    
    Methods:
    : WINTHER is an open label non-randomized clinical trial developed by the WIN consortium to provide a rational personalized therapeutic choice to all (100 %) enrolled patients, irrespective of the type of genomic events. The study includes patients with metastatic cancer who progressed on at least one line of therapy. Matched tumor and normal tissue biopsies are collected from each patient and analyzed by next-generation-sequencing for known oncogenic driver aberrations (Foundation Medicine) or by functional genomics utilizing a prediction model of efficacy developed at Ben Gurion University. Based on these results study leaders from all centers make therapy decisions. The study aim is to compare progression free survival rates between the previous treatment line and the study drug/s. Patient accrual began in 2013 in four international cancer centers. The following is a description of the experience at Sheba Medical Center., specifically focusing on a large sub-population of lung cancer patients.
    
    Results:
    Fifty six patients were screened and biopsied for the study. The majority of patients were diagnosed with lung cancers (52%), with a diverse representation of other malignancies including breast (16%), renal (9%), colon (9%), sarcoma, bladder and head and neck. Successful biopsies yielding sufficient material for genomic analyses were achieved in 35 subjects (63%). Lung biopsy success rates were 75% and 60% respectively for normal and tumor specimens. To date, 11 lung cancer patients were treated with a variety of chemotherapy (1) or biologic agents (11) based on study recommendations while 3 have yet to progress on previous therapy. Targeted genomic alterations included EGFR (3), RET (2), KRAS (2), ALK (1), ErbB2 (1), ErbB3 (1), BRAF (1). We observed a clinical benefit rate (CBR) of 55% (6/11) with 1 subject achieving compete response (CR), 2 partial responses (PR) and 3 stable disease (SD). Subjects recruited during the second year of the study, compared to the first year had a reduced biopsy failure rate, were more likely to receive treatment and achieved an increased clinical benefit.
    
    Conclusion:
    The proposed strategy for tumor genomic analysis based on the comparison of matched tumor and normal biopsies is acceptable and feasible. The experience of the multidisciplinary team is an important contributor to the program’s success.