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DANUBE Trial: Survival Outcomes With Durvalumab in Advanced Urothelial Carcinoma

By: Kayci Reyer
Posted: Sunday, November 1, 2020

According to the results of the phase III DANUBE trial, published in The Lancet Oncology, the PD-L1 inhibitor durvalumab did not result in significant benefit for patients with unresectable, locally advanced or metastatic urothelial carcinoma. In fact, the study did not meet either of its co-primary endpoints. Joaquim Bellmunt, MD, of Harvard Medical School, and colleagues assessed the survival outcomes of durvalumab used as monotherapy as well as in conjunction with the CTLA-4 inhibitor tremelimumab.

The trial included 1,032 patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma who were randomly assigned to receive durvalumab monotherapy (n = 346), durvalumab plus tremelimumab (n = 342), or standard-of-care chemotherapy (n = 344). Patients were stratified by PD-L1 expression. Overall survival was compared between the subpopulation of patients with high PD-L1 expression in the monotherapy versus chemotherapy groups and between patients in the combination therapy versus the intention-to-treat population.

At a median follow-up of 41.2 months, the median overall survival among patients with high expression of PD-L1 was 14.4 months in the monotherapy group versus 21.1 months in the chemotherapy group. The median overall survival in the combination-therapy group was 15.1 months versus 12.1 months in the chemotherapy group.

Grade 3 or 4 adverse events occurred in the majority of patients (60%; n = 188) receiving chemotherapy, with the most common being neutropenia, and in 47 patients (14%) receiving monotherapy and 93 patients (27%) receiving combination therapy, with both groups most commonly experiencing increased lipase levels. Serious treatment-related adverse events were most common in the combination-therapy group (23%; n = 28), followed by the chemotherapy (16%; n = 50) and monotherapy (9%; n = 30) groups. Overall, five patients—two treated with monotherapy, two treated with combination therapy, and one treated with chemotherapy—died due to study drug toxicity.

Disclosure: For full disclosures of the study authors, visit

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