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A phase III, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE)
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- danube NCT02516241 esmo 2020
DANUBE Results at ESMO 2020
Abstract No : Abstract #697O
Indication : Urothelial carcinoma
Intervention : Durvalumab + tremelimumab
Company : Astrazeneca
Technology : PD-1/CTLA-4 Inhibitor
Results:
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.
Conclusion:
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
Executive Summary
Astrazeneca presented its view on the failure of DANUBE Phase III trial, which evaluated Durvalumab with or without tremelimumab in metastatic Urothelial Carcinoma (UC).