READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma

Background: Avelumab first-line (1L) maintenance is recommended as the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression following 1L platinum-based chemotherapy (PBC). We report results from READY, a real-world study of avelumab 1L maintenance in an Italian compassionate use program (CUP). Patients and methods: In this prospective, noninterventional CUP, avelumab was provided on physician's request to patients with la/mUC without disease progression following four to six cycles of 1L PBC, after approval by the local ethics committees, per Italian compassionate use regulations. Results: = 184), median OS (95% CI) was 25.10 months (19.97 months-NE) and not reached (16.05 months-NE), respectively. Clinical benefit was observed across other subgroups, including those based on age and best response to PBC. Any-grade treatment-related adverse events occurred in 112 patients (27.1%). Conclusions: In READY, avelumab 1L maintenance showed clinical benefit in patients in Italy with la/mUC without progression following PBC, including across clinical subgroups, further supporting its use as the standard of care in this setting.