Abstract
104Background: Biomarkers of clinical benefit of immunotherapies, such as non-synonymous mutations, mutational load, PD-L1 IHC and immune signatures, have not been systematically evaluated in mUC patients (pts) treated with anti–PD-L1 agents. Methods: Exploratory analyses of immune and genetic predictors of response to atezo were performed on archival tumor specimens from mUC pts (NCT02108652 cohort 2). PD-L1 expression in tumor samples was assessed by IHC (SP142 assay) and associated with response as determined by RECIST v1.1 (central review). Gene expression was quantified by RNA-seq (Illumina TruSeq RNA Access; n = 195); molecular subtypes were assigned as per TCGA. Mutations were detected by genomic profiling (FoundationOne 315-cancer gene panel; n = 150) to estimate overall load. Results: PD-L1 tumor-infiltrating immune cell (IC) status was associated with CD8+ T effector (Teff) gene expression levels (P < 0.0001). Notably, response to atezo was associated with high expression of CXCL9 (P = 0.0057) a...
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