Avelumab maintenance in patients with metastatic urothelial carcinoma in a real-life expanded-access program

Abstract

Background This study evaluates the real-world efficacy and safety of avelumab maintenance therapy in patients with metastatic urothelial carcinoma (mUC) who did not progress following first-line platinum-based chemotherapy, using data from the Expanded Access Program (EAP). Patients and methods Safety and effectiveness were assessed in patients who received at least one cycle of avelumab. The primary endpoints were overall survival (OS) and progression-free survival (PFS), while secondary endpoints included safety. PFS and OS were estimated using the Kaplan-Meier method. Results The 12-month OS rate was 78% (95% CI, 74.5%-79%), with the median OS not reached. The 12-month PFS rate was 32% (95% CI, 29%-35%), and the median PFS was 5.3 months (95% CI, 3.4-7.1). Univariate analysis showed a median PFS of 2.9 months in patients with liver metastases versus 5.4 months in those without (p = 0.001), 2.8 months in patients with hemoglobin levels below 10 mg/dL versus 5.3 months in those above (p = 0.06), and 8.8 months in patients with lymph node - only metastases versus 4.1 months in patients with metastases at other sites (p = 0.05). No significant differences in PFS were observed based on chemotherapy type (cisplatin vs. carboplatin, p = 0.7), chemotherapy cycle count (<= 4 vs. > 4 cycles, p = 0.4), or first-line chemotherapy response (complete response vs. partial response/stable disease, p = 0.4). Conclusions Avelumab demonstrated efficacy and tolerability as maintenance therapy for mUC patients without progression following first-line platinum-based chemotherapy.