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Durvalumab
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Durvalumab is an anti–PD-L1 monoclonal antibody with activity when given perioperatively with neoadjuvant chemotherapy in patients with resectable disease. However, durvalumab was voluntarily withdrawn in 2021 as a first-line therapy for locally advanced or metastatic urothelial cancer. The withdrawal was based on the randomized DANUBE trial (NCT02516241) which showed no significant improvement in OS.[51][Level of evidence A1]
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Durvalumab was assessed as second-line therapy after platinum-based chemotherapy or for cisplatin-eligible patients.
Evidence (durvalumab):
The efficacy of durvalumab (10 mg/kg IV every 14 days) was assessed in a study (NCT01693562) of 191 patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed while they were on chemotherapy or who were either ineligible for or unwilling to be treated with chemotherapy.[52][Level of evidence C3]
Source links and citations
The efficacy of durvalumab (10 mg/kg IV every 14 days) was assessed in a study (NCT01693562) of 191 patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed while they were on chemotherapy or who were either ineligible for or unwilling to be treated with chemotherapy.[52][Level of evidence C3]
With a median follow-up of 5.78 months, the overall response rate was 17.8%.
The efficacy of durvalumab (10 mg/kg IV every 14 days) was assessed in a study (NCT01693562) of 191 patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed while they were on chemotherapy or who were either ineligible for or unwilling to be treated with chemotherapy.[52][Level of evidence C3]
The response rate was 27.6% in patients with high expression of PD-L1 compared with 5.1% in patients with low or no PD-L1 expression.
The efficacy of durvalumab (10 mg/kg IV every 14 days) was assessed in a study (NCT01693562) of 191 patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed while they were on chemotherapy or who were either ineligible for or unwilling to be treated with chemotherapy.[52][Level of evidence C3]
High-grade adverse events were reported in 6.8% of patients, including 2.1% with high-grade immune-mediated adverse events.
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Preserved source evidence · Not medical advice