Economic Analysis of Avelumab Maintenance in la/mUC

This economic analysis was based on the JAVELIN Bladder 100 study (data cutoff: October 21, 2019) [9 ]. The study was conducted at 197 sites (99 in Europe, including 17 in France) and enrolled 700 patients with histologically confirmed la/mUC who had completed 4 to 6 cycles of platinum-based chemotherapy followed by an interval of 4 to 10 weeks. Patients were randomized (1:1) to receive either avelumab 1L maintenance (10 mg/kg intravenously every 2 weeks) plus BSC or BSC alone. A total of 82 French patients were included in the study, making France the second largest patient population by country in the trial. The characteristics of patients in JAVELIN Bladder 100 were compared with data from a retrospective observational study (chart review) conducted as part of the present analyses to ensure that they were comparable with the French population. The retrospective study used medical records from 206 French patients aged ≥18 years, with advanced UC who had received 1L treatment with gemcitabine and a platinum agent without disease progression (Table 1) [14 (link)]. Based on these data, the comparability of JAVELIN Bladder 100 patient characteristics to French patients with la/mUC was confirmed (Table 1). The primary objective of the JAVELIN Bladder 100 study was to demonstrate the superiority of avelumab 1L maintenance plus BSC compared with BSC alone in terms of OS. The median duration of treatment was 24.9 weeks in the avelumab plus BSC arm and 13.1 weeks in the BSC alone arm. Median OS was 21.4 months (95% CI [18.9–26.1]) in the avelumab plus BSC arm versus 14.3 months (95% CI [12.9–17.9]) in the BSC alone arm. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) version 4.03 [7 (link)]. Costs and effects of avelumab plus BSC were compared with those of BSC alone in the absence of other therapeutic alternatives for 1L maintenance of patients with la/mUC according to French and European guidelines [4 (link), 7 (link), 15 (link), 16 (link)].