Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE ‐Bladder Study
Ilya Tsimafeyeu, Yana Gridneva, Alexander Sultanbaev, Yulia Anzhiganova, Mark Gluzman, Anastasia Mochalova, Alexey Shkurat, Edgar Israelyan, Elvira Parsadanova, Yulia Murzina, Aleksei Ivanov, Alexey Kalpinskiy, Olesia Stativko, Vladislav Petkau, Elena Karabina, Artyom Kеln, Natalya Tovbik, Sufia Safina, Maria Turganova, Evgeny Kopyltsov, Varvara Bragina, Olga Novikova, Andrei Lebedinets, Vladislav Vodolazskiy, Alexey Rumyantsev, Ruslan Zukov, Ilya Pokataev, Rashida Orlova, Maria Volkova ABSTRACT
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