Virtual Library

Start Your Search

Jody Schulz



Author of

  • +

    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
    • +

      P2.01-99 - Can NGS NSCLC Testing Be Implemented Without in House Expertise? Clinical Utility of the First FDA-Approved Lung Cancer NGS End-To-End Solution (ID 14069)

      16:45 - 18:00  |  Author(s): Jody Schulz

      • Abstract
      • Slides

      Background

      Clinical utility and advantages of in-house NSCLC NGS testing compared with send-out testing are: shorter turn-around times for faster treatment, better tissue stewardship, and maintenance of specimen control within institutions, fostering direct communication between pathologists and oncologists on the most effective testing and treatment paradigms. Despite obvious benefits, in-house NGS testing widespread use has not occurred due to the need for specialized personnel, extensive hands-on time, and complexity in developing/validating home-brew panels, and bioinformatics result interpretation. To overcome these difficulties, Thermo Fisher Scientific developed the Oncomine™ Dx Target Test (ODxTT) to identify NSCLC guideline-recommended EGFR, ROS1, or BRAF mutations for their associated treatment with gefitinib, crizotinib, or dabrafenib/trametinib, respectively. This is the first FDA-approved NGS companion diagnostic test commercially available that can be implemented in local laboratories.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Clinical utility measured by objective response rate (ORR), and duration of response (DOR) in NSCLC patients was evaluated initially utilizing local laboratory tests (LLTs) and compared with the ODxTT across mutations and associated therapies.

      4c3880bb027f159e801041b1021e88e8 Result

      Comparison of ODxTT with the NSCLC BRAF V600E PCR assay in patient samples showed 100% (181/181; 95%CI 97.9-100%) overall percent agreement (OPA, excluding no calls). Clinical efficacy of the ODxTT in 2 cohorts with stage IV NSCLC treated with dabrafenib/trametinib (BRF113928 clinical trial) measured as ORR was 68.2% (15/22) for Cohort B and 60.9% (14/23) for Cohort C, which was similar to the results achieved with the LTT 63.2% ORR (36/57) for Cohort B and 61.1% ORR (22/36) for Cohort C. ORR of 83.3% (5/6; 95%CI: 35.88-99.58%) was achieved with crizotinib with an accompanying DOR of 17.5 months (N=5, 95%CI: 10.9-24.1) which tested positive with the ODxTT in patient samples (Phase-1, Pfizer-Study A8081001). OPA of 99.0% (188/190; 95%CI 96.25-99.87%) was achieved for EGFR Exon 19 deletion and 100% (197/197; 95%CI: 98.14-100%) for EGFR L858R with the ODxTT versus the Qiagen TheraScreen EGFR RGQ PCR Kit.Estimate repeatability of the ODxTT at each variant location was ≥98.8% (DNA) and 94.4% (RNA).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The FDA approved ODxTT demonstrated clinical utility by accurately detecting guideline-recommended mutations for the selection of associated targeted therapies eliminating additional expertise required to validate, implement, and run NGS LLTs.

      "For In vitro diagnostic use"

      6f8b794f3246b0c1e1780bb4d4d5dc53

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.