Author of

• 18502

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  P3.02c - Poster Session with Presenters Present (ID 472)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18576

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    P3.02c-074 - Evaluation of a Pretreatment Serum Tests for Nivolumab Benefit in Patients with Non-Small Cell Lung Cancer (ID 5505)

    14:30 - 14:30  |  Author(s): M. Tsypin
    • Abstract

    Background:
    Anti-PD1 inhibitors are becoming the treatment of choice for 2[nd] line non-small cell lung cancer (NSCLC). While existing testing for PDL-1 expression may correlate with anti-PD1 benefit, current data do not support these tests to be sufficient to guide therapy. We evaluated the utility of a serum-based pre-treatment test first developed to identify patients benefitting from anti-PD1 therapy in metastatic melanoma[1] in patients with NSCLC. These results were compared to the data obtained from application of the established VeriStrat[2] test to the same samples.
    
    Methods:
    60 advanced NSCLC patients treated with nivolumab in an observational study were included. Pretreatment serum samples were classified using the fully locked mass spectrometry-based multivariate tests BDX008 and VeriStrat. BDX008 generates a classification of positive (BDX008+, good outcomes) or negative (BDX008-, poor outcomes); VeriStrat classifies samples as Good and Poor. The association of test classifications with overall survival (OS), progression-free survival (PFS), and time-to-failure (TTF) were assessed using Kaplan-Meier method and Cox proportional hazards model.
    
    Results:
    37% of patients were classified as BDX008+ and 63% as BDX008-; 62% were classified as VeriStrat Good and 38% as Poor. Both tests significantly stratified OS (Table), but not PFS or TTF, and remained significant for OS in multivariate analyses (p=0.0167 and 0.0184, for BDX008 and VeriStrat, respectively). Out of 11 patients who died before the first radiological evaluation, 10 were classified as BDX008-, 9 as VeriStrat Poor.

    Test	Log-rank p value	CPH HR [95% CI]	Median Survival (months) [95% CI]
    BDX0008 (+ vs -)	0.0026	0.189 [0.056-0.637]	BDX0008+: Not reached BDX0008-: 5.5 [2.6-11.9]
    VeriStrat (Good vs Poor)	0.0186	0.390 [0.173-0.880]	VS Good: Not reached VS Poor: 4.1 [1.0-Undef.]

    
    
    Conclusion:
    BDX008 developed for immunotherapy of patients with melanoma can be applied to NSCLC patients, and shows a significant separation for OS. Clinical utility of BDX008 will need to be further evaluated. VeriStrat is also prognostic for the same patients. 1. J. Weber et al, “Pre-treatment patient selection for nivolumab benefit based on serum mass spectra”, SITC 2015. 2. V. Gregorc et al, The Lancet Oncology, p713, 15(7), 2014.