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Avelumab as Second-Line Treatment for Advanced Urothelial Carcinoma

By: Sarah Campen, PharmD
Posted: Monday, January 29, 2018

Treatment with avelumab showed “promising” antitumor activity in patients with platinum-refractory metastatic urothelial carcinoma, according to Manish R. Patel, MD, of the Sarah Cannon Research Institute in Sarasota, Florida, and colleagues. The results of the analysis, published in The Lancet Oncology, also revealed that avelumab, a PD-L1–blocking antibody, appears to be well tolerated in this population.

A planned pooled analysis of 2 expansion cohorts of the open-label JAVELIN Solid Tumor trial, the study included 249 patients with locally advanced or metastatic urothelial carcinoma that had progressed after at least one previous platinum-based chemotherapy. Patients received avelumab (10 mg/kg via 1-hour intravenous infusion) every 2 weeks until disease progression or unacceptable toxicity was reached.

The patients received treatment with avelumab for a median of 12 weeks and were followed for a median of approximately 10 months. In the 161 postplatinum patients with at least 6 months of follow-up, 9 patients (6%) had a complete response and 18 (11%) had a partial response to avelumab. The overall disease control rate was 40%. In the full cohort, 58% of patients experienced any grade 1 or 2 event, with infusion-related reaction and fatigue as the most frequent treatment-related adverse events.

The investigators also evaluated patient response based on PD-L1 tumor expression status. Patients with PD-L1–positive tumors had a disease control rate of 52% versus 33% in those with PD-L1-negative tumors.