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. 2025 Feb;14(4):e70636.
doi: 10.1002/cam4.70636.

Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study

Ilya Tsimafeyeu  1 , Yana Gridneva  2 , Alexander Sultanbaev  3 , Yulia Anzhiganova  4 , Mark Gluzman  5 , Anastasia Mochalova  6 , Alexey Shkurat  7 , Edgar Israelyan  8 , Elvira Parsadanova  9 , Yulia Murzina  10 , Aleksei Ivanov  11 , Alexey Kalpinskiy  12 , Olesia Stativko  2 , Vladislav Petkau  13 , Elena Karabina  14 , Artyom Kеln  15 , Natalya Tovbik  16 , Sufia Safina  17 , Maria Turganova  18 , Evgeny Kopyltsov  19 , Varvara Bragina  20 , Olga Novikova  21 , Andrei Lebedinets  7 , Vladislav Vodolazskiy  19 , Alexey Rumyantsev  8 , Ruslan Zukov  22 , Ilya Pokataev  2 , Rashida Orlova  5 , Maria Volkova  2
Affiliations

Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study

Ilya Tsimafeyeu et al. Cancer Med. 2025 Feb.

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.

Keywords: avelumab; maintenance therapy; metastatic urothelial carcinoma; real‐world data.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Overall and progression‐free survival (Kaplan–Maier curves).
FIGURE 2
FIGURE 2
Duration of response in assessed patients.
See this image and copyright information in PMC

References

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