DANUBE Results at ESMO 2020

Abstract No : Abstract #697O

Indication : Urothelial carcinoma

Intervention : Durvalumab + tremelimumab

Company : Astrazeneca

Technology : PD-1/CTLA-4 Inhibitor


A total of 1032 pts were randomized. Median OS was not significantly different between D and CT (14.4 vs 12.1) among pts with high PD-L1 expression, nor between D+T and CT in the ITT population.Treatment-related adverse events of grade 3–4 occurred in 14%, 28%, and 60% of pts in the D, D+T, and CT arms, with deaths possibly related to treatment in 0.6%, 0.6%, and 0.3% of pts, respectively.


While a trend towards improved OS was observed with D vs CT in the PD-L1 high population and with D+T vs CT in the ITT population, statistical significance was not reached. Additional analyses are ongoing to characterize D and D+T efficacy/safety in different pt subgroups