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: Between January 2021 and March 2022, 414 patients received avelumab 1L maintenance and were assessable for survival/safety analyses; 79.2% were male and median age was 71 years. At data cut-off (30 July 2023), median follow-up was 20.30 months [95% confidence interval (CI) 19.78-20.93 months]. From the start of avelumab treatment, median overall survival (OS) was 26.22 months [95% CI 19.97 months-not estimable (NE); 12-month OS rate, 65.6%] and median progression-free survival was 7.63 months (95% CI 6.02-9.31 months). In patients who had received 1L carboplatin plus gemcitabine (n = 221) or cisplatin plus gemcitabine (n = 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.