Nivolumab shows encouraging efficacy and acceptable safety in patients with previously treated metastatic urothelial cancer, investigators reported at the European Society for Medical Oncology 2016 congress in Copenhagen suggest.

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues studied 78 patients with metastatic urothelial cancer who received nivolumab 3 mg/kg IV every 2 weeks until progression or discontinuation. The patients were unselected by PD-L1 expression status. Of these, 52 received 2 or more previous therapies. At a minimum follow-up of 9 months, 23.1% of patients were on monotherapy and 23.1% switched to combination therapy. Treatment discontinuation was mainly due to disease progression.

With regard to overall efficacy, the objective response rate (ORR) was 24.4%, median progression-free survival (PFS) was 2.8 months, and median overall survival was 9.7 months, according to the investigators. The median time to response was 1.5 months.

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The ORR was 26.2% among patients who had PD-L1 expression of less than 1% and 24% among those with PD-L1 expression of 1% or greater, Dr Rosenberg and colleagues reported. Median PFS was 5.5 months and 2.8 months, respectively.

Grade 3 or 4 treatment-related adverse events occurred in 21.8% of patients. Most frequent were elevated lipase and amylase levels, fatigue, decreased neutrophil and lymphocyte counts, rash, and dyspnea.

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1. Rosenberg JE, et al. Nivolumab monotherapy in metastatic urothelial cancer (mUC): Updated efficacy by subgroups and safety results from the CheckMate 032 study. Data presented at the European Society for Medical Oncology 2016 congress in Copenhagen, Denmark, October 7–11. Poster 784P. Ann Oncol 2016;27 (Suppl 6):vi271.