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Thomas Flaig, MD


STRONG Trial: Durvalumab Monotherapy for Urinary Tract Carcinoma

By: Jenna Carter, PhD
Posted: Friday, March 25, 2022

A treatment update on the use of the anti–PD-L1 agent durvalumab in patients with urinary tract carcinoma was published in the European Journal of Cancer. Sebastien J. Hotte, MD, of the Juravinski Cancer Center, Hamilton, Ontario, Canada, and colleagues conducted the phase IIIb STRONG study to investigate the safety and efficacy of a fixed-drug dose in a previously treated patient population. Their findings revealed that the median overall survival was 7 months, and the objective response rate was 18%, with a complete response in 5% of patients.

“Patients with advanced urinary tract carcinoma failing first-line platinum-based chemotherapy have a poor prognosis…. STRONG afforded the opportunity to evaluate durvalumab’s safety and efficacy in the every-4-week fixed-dosing regimen in a large study…[across] several countries and settings, reflecting the real-world clinical experience,” stated Dr. Hotte and colleagues.

A total of 867 patients with urothelial or non-urothelial urinary tract carcinoma were included in this study. Patients whose disease progressed after platinum or non-platinum chemotherapy were treated with durvalumab at 1,500 mg every 4 weeks. The primary study endpoint was the incidence of adverse events of special interest, including immune-mediated adverse events. The secondary endpoints included objective response rate, overall survival, and disease control rate.

Overall findings revealed that 91% of patients had any grade of adverse events; however, 41% of patients had events at grade 3 or higher. The median overall survival was 7.0 months (95% confidence interval [CI] = 6.4–8.3 months). Additionally, the overall survival rates at 1 and 2 years were 35.8% (33%–39%) and 20% (17%–24%), respectively. Based on these findings, Dr. Hotte and colleagues concluded that fixed-dose durvalumab has an acceptable safety profile in previously treated patients and resulted in tumor objective responses consistent with other published evidence. 

Disclosure: For full disclosures of the study authors, visit

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