Results from the phase 3 DISCUS trial suggest that 3 cycles of platinum-based chemotherapy prior to avelumab maintenance may offer comparable efficacy and safety compared to the standard 6 cycle regimen among patients with advanced urothelial carcinoma.

These data were presented by Enrique Grande, MD, PhD, MD Anderson Cancer Center, Madrid, Spain, at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany. 

In this open-label study, 267 previously untreated patients were randomized 1:1 to receive either 3 (n = 133) or 6 (n = 134) cycles of gemcitabine plus cisplatin or carboplatin followed by maintenance avelumab. Dual primary end points included patient-reported outcomes (PROs) and overall survival (OS). Key secondary end points included additional PRO analysis, progression-free survival (PFS), objective response rate (ORR), and safety. 

At analysis, the mean quality of life change from baseline and cycle 6 was 0.0 in the 3-cycle arm and -8.5 in the 6-cycle arm. (P = .016). Improvements in PRO scores was observed in 41% and 24% of patients, respectively. The ORR was 24% in the 3-cycle arm and 27% in the 6-cycle arm. Median PFS was 8 months in the 3-cycle arm and 9 months in the 6-cycle arm (HR 1.05; 95% confidence interval [CI], 0.73 to 1.53; P = .79) and median OS was 18.9 in both treatment arms (HR 1.15; 95% CI, 0.72 to 1.86; P = .56). Grade 3/4 treatment-related adverse events occurred in 11.9% and 15.7% of patients, respectively. 

“Three cycles of platinum-based chemotherapy followed by avelumab provides better QoL compared with six cycles, and similar OS without compromising efficacy,” concluded Dr Grande et al.

Source:

Grande E, Hussain SA, Duran MAC, et al. DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer. Presented at the 2025 ESMO Congress; October 17-21, 2025. Berlin, Germany. LBA109