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A. Galvano



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    ORAL 31 - PD1 Axis Inhibition (ID 143)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL31.01 - PD-L1 Expression as Predictive Biomarker in Patients with NSCLC: A Pooled Analysis (ID 1578)

      16:45 - 18:15  |  Author(s): A. Galvano

      • Abstract
      • Presentation
      • Slides

      Background:
      Clinical trials of immune checkpoints modulators, including both programmed cell death-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) inhibitors, have recently shown promising activity and tolerable toxicity in pre-treated NSCLC patients. However the predictive role of PD-L1 expression is still controversial. This pooled analysis aims to clarify the association of clinical objective responses to anti PD-1/PD-L1 monoclonal antibodies (MoAbs) and PD-L1 expression in pre-treated NSCLC patients.

      Methods:
      Data from all published studies, that evaluated efficacy and safety of PD-1/PD-L1 inhibitors in pre-treated NSCLC patients, stratified by tumor PD-L1 expression status (immunohistochemistry, cut-off point 1%), were collected by searching in PubMed, Cochrane Library, American Society of Clinical Oncology, and World Conference of Lung Cancer, meeting proceedings. Pooled Odds ratio (OR) and 95% confidence intervals (95% CIs) were calculated for the Overall Response Rate (ORR) (as evaluated by Response Evaluation Criteria in Solid Tumors, version 1.1), according to PD-L1 expression status.

      Results:
      A total of six studies, with 776 patients, were eligible. Pooled analysis showed that patients with PD-L1 positive tumors (PD-L1 tumor cell staining ≥1%), had a significantly higher ORR, compared to patients with PD-L1 negative tumors (OR: 2.53; 95% CIs: 1.65-3.87). Figure 1Figure 2





      Conclusion:
      PD-L1 tumor expression seems to be associated with clinical activity of anti PD-1/PD-L1 MoAbs, in pre-treated, NSCLC patients, suggesting a potential role of PD-L1 expression, IHC cut-off point 1%, as predictive biomarker for the selection of patients who may benefit more from these therapies. Further analysis from ongoing phase II/III clinical trials will provide more information about this observation.

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