Durvalumab may be an effective treatment option for programmed cell death ligand-1 (PD-L1)-positive patients with advanced urothelial bladder cancer (UBC), according to a study published in the Journal of Clinical Oncology.1

Sixty-one patients with inoperable or metastatic UBC, of which 40 were PD-L1-positive and 21 were PD-L1 negative, were enrolled in this phase 1/2 multicenter, open-label study. 93.4% of these patients had been treated previously for advanced disease.

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Among PD-L1-positive patients, 46.4% (95% CI, 27.5-66.1) met the objective response rate (ORR), while 0% (95% CI, 0.0-23.2) of PD-L1-negative patients met the ORR. Responses are ongoing in 12 of 13 patients for whom the drug has been effective.

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The authors concluded that durvalumab displayed evidence of meaningful clinical activity in PD-L1-positive patients with UBC. The safety profile was referred to as “manageable,” though adverse events included fatigue (13.1%), diarrhea (9.8%), decreased appetite (8.2%), as well as instances of grade 3 adverse events in 4.9% of patients. One patient experienced an acute kidney injury and discontinued treatment.


  1. Massard C, Gordon MS, Sharma S, Rafii S, Wainberg ZA, Luke J, et al. Safety and efficacy of durvalumab (MEDI4736), an anti–programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer [published online ahead of print June 6, 2016]. J Clin Oncol. doi: 10.1200/JCO.2016.67.9761.