Yousef Zakharia, MD, clinical associate professor of internal medicine at the University of Iowa, Holden Comprehensive Cancer Center, discusses the results of a phase 2 trial (NCT02891161) investigating concurrent durvalumab (Imfinzi) and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder.
This study enrolled 26 patients and the investigators had efficacy data for 24 patients. This regimen was deemed safe for use in patients and the safety has been presented prior to the efficacy. There were no major dose-limiting toxicities with this combination, according to Zakharia.
In the 24 evaluable patients, there was a disease control rate of 72% at the end of 1 year. After the completion of adjuvant daratumumab, there were 10 complete response, 3 partial responses, 1 patient with stable disease, and 6 patients with progressive disease. Zakharia says the progression-free survival rate was about 70%. The 1-year overall survival probability was 83.8% and the 2-year probability was 76.8%. The median overall survival had not been reached.