Real-World Efficacy of Enfortumab Vedotin for Patients With Advanced Urothelial Carcinoma
Results from a retrospective, real-world analysis confirmed that enfortumab vedotin is a safe and effective treatment option for patients with locally advanced or metastatic urothelial carcinoma.
“Enfortumab vedotin represents a novel treatment for patients with locally advanced or metastatic urothelial carcinoma refractory to platinum-based chemotherapy and PD(L)-1 containing therapies,” wrote Dora Niedersuess-Beke, MD, Vienna Healthcare Group, Vienna, Austria, and coauthors. “Real-world data are crucial for informing health policy decisions and validating clinical trial findings.”
In this multicenter study, researchers collected data from 128 patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin monotherapy. Primary end points included objective response rate (ORR), disease control rate, median progression-free survival (PFS), median overall survival (OS), and safety.
At analysis, the ORR was 31%. The disease control rate was 47% with 9% of patients in complete remission, 23% of patients in partial remission, and 16% of patients with stable disease. At a median follow-up of 6.2 months, the median PFS was 4.8 months and the median OS was 10.75 months. Significantly better OS was seen among patients with good performance status, metachronous metastatic disease, and those without the presence of liver metastases. Grade ≥3 adverse events occurred in 25.8% of patients. Dose reductions due to adverse events did not affect efficacy.
“In our real-world population, the administration of [enfortumab vedotin] was feasible and effective, with no new safety signals, " concluded Dr Niedersuess-Beke et al. “Our data corroborate the efficacy and safety of [enfortumab vedotin] monotherapy in later lines.”
Source:
Niedersuess-Beke D, Mayrhofer K, Krauter J, et al. Real-world evidence for enfortumab vedotin in patients with metastatic urothelial cancer: An austrian multicentre study. Clin Genitourin Cancer. Published online: November 21, 2024. doi: 10.1016/j.clgc.2024.102278
