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Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective
Ilya Tsimafeyeu1, Yana Gridneva2, Alexander Sultanbaev3
1Bureau of Cancer Research-Moscow Office, Moscow, Russian Federation.
Background:
This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real-world population of patients with metastatic urothelial cancer (UC).
Methods:
Patients with metastatic UC and measurable disease that had not progressed following first-line platinum-based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS).
Results:
A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36-84). The median OS was not reached, with a 1-year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8-11.2 months). The ORR to first-line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients.
Conclusions:
These findings demonstrate similar efficacy and safety of avelumab in a real-world setting when compared to data from pivotal study.
Trial Registration:
KCRB registry number: RAVE-Bladder.
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