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R. Xu



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    MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA14.05 - Implications of Implementation of a PD-L1 Biomarker-Based Strategy for Treatment of Advanced NSCLC (ID 5042)

      16:00 - 17:30  |  Author(s): R. Xu

      • Abstract
      • Presentation
      • Slides

      Background:
      The KEYNOTE-010 (KN010) clinical trial, a multi-center, worldwide, randomized Phase II/III trial of pembrolizumab 2m/kg every 3 weeks and docetaxel 75mg/m2 every 3 weeks in patients with previously treated advanced NSCLC with PD-L1 positive tumors showed a significant overall survival (OS) advantage for patients receiving pembrolizumab. We examined the improvement in prognoses for patients who elect to learn their PD-L1 biomarker results using extrapolative survival modeling.

      Methods:
      Partitioned survival models to project long-term outcomes were developed using data from patients enrolled in KN010, with treated patients in the pembrolizumab 2m/kg and docetaxel 75mg/m2 arms included in these analyses. As OS for docetaxel patients is not dependent on PD-L1 status, KN010 results were assumed to represent docetaxel efficacy in all patients irrespective of PD-L1 status.The model projected expected lifetime using Kaplan Meier estimates of PFS and OS from the trial with extrapolation based on parametric functions and long term registry data.

      Results:
      Results directly from KN010 showed for patients with TPS≥50%, median survival to be 8.2 months (6.4, 10.7) and 14.9 months (10.4, NA) for docetaxel and pembrolizumab, respectively (HR= 0.54 (0.38, 0.77)). Model-based projections show that should all patients be treated with docetaxel, expected mean lifetime is 1.0 years. For patients receiving a PD-L1 biomarker test per KN010 28.49% will be identified as PD-L1 strong positive (TPS≥50%). PD-L1 (TPS ≥50%) predicts a life expectancy with biomarker directed pembrolizumab of 2.25 years on average.

      Conclusion:
      Use of PD-L1 biomarker identification can significantly improve OS prognoses for patients considering pembrolizumab and docetaxel with advanced NSCLC based on both clinical trial results and model-based projections from KN010.

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