Abstract
4500 Background: This prospective biomarker study in patients (pts) with mRCC treated with the programmed death-1 (PD-1) inhibitor antibody nivolumab assessed baseline (BL) and changes in serum chemokines, tumor T cell infiltrates (TIL), gene expression, T cell repertoire (TCR), and other biomarkers potentially associated with clinical outcomes (NCT01358721). Methods: Pts treated with 1–3 prior therapies received nivolumab 0.3, 2, or 10 mg/kg IV Q3W; treatment-naive pts received 10 mg/kg IV Q3W. Biopsies were obtained at BL and cycle 2 day 8. Overall survival (OS) parameters were estimated by Kaplan-Meier method. Tumor PD-L1 expression was measured by immunohistochemistry (28-8 antibody; Dako). PD-L1 positivity was defined as ≥ 5% tumor membrane staining in ≥ 1 biopsy; tumor burden response as ≥ 20% reduction. Gene expression data were obtained on Affymetrix U219. Results: 91 pts were treated. Of 56 evaluable BL biopsies, 32% were PD-L1+. Median OS (95% CI) was 16.4 mo (10.1–not reached [NR]) for 0.3 mg/k...
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