Akademik Veri Yönetim Sistemi
CLINICAL GENITOURINARY CANCER, cilt.1, ss.1, 2026 (SCI-Expanded, Scopus)
ackground
Enfortumab vedotin plus pembrolizumab (EV+P) is an established standard of care for metastatic urothelial carcinoma; however, real-world data remain limited. We evaluated clinical outcomes in patients treated in the frontline metastatic setting.Patients and Methods
The primary endpoint was objective response rate (ORR); secondary endpoints included overall survival (OS), progression-free survival (PFS), duration of response, and safety. Median follow-up and survival outcomes were estimated using reverse and standard Kaplan–Meier methods and Cox regression analyses.Result
Overall, 160 patients were included, with 148 (92.5%) receiving EV+P in the 1L. The median follow-up was 14 months(mo). In the 1L, the median PFS was 12 mo (95%CI, 6.4–17.6).The CR rate was 14.9% and the PR rate was 54.1%, resulting in an ORR of 69.0%. SD and PD were observed in 16.9% and 14.1% of patients, respectively. Among patients achieving CR or PR, the median duration of response was 20 mo (95% CI, 11.3–28.6). In univariate analyses for PFS, patients with upper urinary tract tumors had significantly shorter PFS compared with those with lower urinary tract tumors (5 vs 20 mo, p=0.004). Patients with ECOG PS ≥2 had shorter PFS than those with ECOG PS ≤1 (3 vs 16 mo; p=0.002). De novo metastatic disease was associated with worse PFS (6 vs 23 mo, p=0.07). In the 1L EV+P cohort, 12- and 24-month OS rates were 73.8% and 57.7%, respectively. In the ≥2-line cohort (n=12), the ORR was 66.7%, with PR in 58.4% and CR in 8.3%; SD and PD were observed in 8.3% and 25.0% of patients, respectively. Overall, 80.6% of patients experienced at ≥1 treatment-related adverse event (TRAEs) of any grade, and 19 patients (13.7%) developed grade 3–4 TRAEs.Conclusions
In this real-world cohort, EV+P demonstrated meaningful clinical activity and manageable safety as frontline therapy, consistent with EV-302.