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.
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.
- 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.