Multicenter prospective study of real-world effectiveness of avelumab maintenance in advanced urothelial carcinoma

The multicenter prospective MALVA Study in Italy (including a retrospective cohort of patients treated before study initiation) evaluated real-world effectiveness of avelumab maintenance in 251 patients with advanced urothelial carcinoma who responded to first-line platinum-based chemotherapy. Median progression-free survival was 7 months and median overall survival was 22.4 months; the objective response rate was 27% and the disease control rate was 69%. Multivariate analysis identified ECOG performance status ≥1 (HR 1.57), bone metastases (HR 1.99), brain metastases (HR 7.02), and baseline steroid use (HR 2.42) as independent predictors of worse overall survival.ECOG performance status ≥ 1, presence of bone metastases, and corticosteroid use at baseline were identified as independent prognostic factors, and were used to construct exploratory stratification into three prognostic groups. Patients with none, one, or two or more negative factors was significantly different OS (median: 39.9 versus 14.1 versus 8.4 months) and ORR (33.6% versus 28.0% versus 6.9%). The authors conclude that in this real-world cohort, avelumab maintenance confirmed its effectiveness in advanced urothelial carcinoma.