TMB, and CD8 T cell infiltration and IFN-γ signature scores (Table) were positively associated with DFS in the NIVO arm. Of 709 randomized pts, 458, 445, and 323 were evaluable for TMB, CD8 IHC, and RNA-seq. Cox proportional hazards models were used to assess association between DFS and biomarkers (continuous scale) and estimate treatment-effect hazard ratios (HRs NIVO vs PBO) for biomarker tertile subgroups. Gene signature scores were computed from RNA-seq data. CD8+ immune cell infiltration was measured with digital immunohistochemistry (IHC). Tumor mutation burden (TMB mutations/MB) was measured by whole exome sequencing. Pre-treatment tumor tissue from the most recently resected site or the transurethral resection yielding MIUC diagnosis was provided for biomarker analyses. Pts were randomized 1:1 to NIVO 240 mg IV every 2 weeks or PBO for ≤ 1 year of adjuvant treatment. We report exploratory analyses (minimum follow-up, 11.0 months) of associations between pre-treatment tumor and immune features and DFS to identify patients (pts) who may potentially benefit most from adjuvant NIVO. 17 Department Of Medicine, Icahn School of Medicine at Mount Sinai, 10029 - New York/USĬheckMate 274 (NCT02632409), a phase 3 trial of adjuvant nivolumab (NIVO) vs placebo (PBO) in high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection, demonstrated improved disease-free survival (DFS) with adjuvant NIVO vs PBO in the intent-to-treat (ITT) and tumor PD-L1 expression ≥ 1% populations.16 Translational Medicine, Bristol Myers Squibb, 08540 - Princeton/US. 15 Department Of Clinical Research, Bristol Myers Squibb, Princeton/US.14 Translational Bioinformatics, Bristol Myers Squibb, 08548 - Princeton/US.13 Translational Bioinformatics, Bristol Myers Squibb, 08536 - Princeton/US.12 Translational Medicine, Bristol Myers Squibb, Princeton/US.11 Department Of Oncology, University Hospital Basel, 4031 - Basel/CH.10 Department Of Urology, Jena University Hospital, 07747 - Jena/DE.9 Department Of Urology, Sapporo Medical University, 060-8543 - Sapporo/JP.8 Department Of Medicine, University of North Carolina School of Medicine, 27514 - Chapel Hill/US.7 Department Of Oncology, Rambam Health Care Center, 3109601 - Haifa/IL.Thomas’ NHS Foundation Trust, SE1 9RT - London/GB 6 Department Of Oncology, Guy’s and St.5 Department Of Oncology, Aarhus University Hospital, 8000 - Aarhus/DK.4 Department Of Urology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN.3 Department Of Urology, Niigata University Graduate School of Medical and Dental Sciences, 951-8520 - Niigata/JP.2 Department Of Medicine, Memorial Sloan Kettering Cancer Center, 10065 - New York/US.1 Department Of Medical Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, 20132 - Milan/IT.
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