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.