Translating avelumab maintenance into clinical practice: nationwide outcomes in Czech patients with advanced or metastatic urothelial carcinoma

BACKGROUND: Platinum-based chemotherapy (PBC) followed by avelumab first-line (1L) maintenance for patients with nonprogressive disease is a standard of care in locally advanced or metastatic urothelial carcinoma (la/mUC) in the Czech Republic. We report results from a retrospective analysis of a national reimbursement registry for avelumab maintenance. The objective was to assess the effectiveness and safety in routine clinical practice. METHODS: Registry data were collected between October 2021 and January 2024. Primary endpoint was overall survival (OS) from avelumab 1L maintenance; secondary endpoints included progression-free survival (PFS) and safety. RESULTS: At data cutoff, 107 patients with la/mUC were treated with avelumab 1L maintenance, the median age was 72 years (range, 45-92), and the median follow-up was 8.2 months. Fifty-five patients (51.4%) received 1L cisplatin-based chemotherapy, 46 (43.0%) carboplatin-based chemotherapy, and six (5.6%) switched between regimens. Median OS was not reached, the 12- and 18-month OS rates were 79.3% and 68.0%. Limitations include low number of patients, retrospective design, and short follow-up. CONCLUSIONS: These clinical outcomes are consistent with the JAVELIN Bladder 100 trial and other real-world studies, supporting the effectiveness and favorable safety profile of avelumab as 1L maintenance in patients with la/mUC that has not progressed with 1L PBC.