Maintenance therapy with avelumab as the first-line treatment in patients with metastatic urothelial carcinoma: A real-world, ambispective RAVE-Bladder study.

person Yana Gridneva Moscow City Oncological Hospital No.1, Moscow, Russian Federation info_outline Yana Gridneva, Alexander Sultanbaev, Yulia Anzhiganova, Mark Gluzman, Anastasia Mochalova, Alexey Shkurat, Elvira Parsadanova, Edgar Israelyan, Yulia Murzina, Aleksey Kalpinsky, Olesia Stativko, Elena Karabina, Artyom Kеln, Vladislav Petkau, Natalya Tovbik, Maria Turganova, Sufiia Safina, Evgeny Kopyltsov, Maria Volkova, Ilya Tsimafeyeu

Authors person Yana Gridneva Moscow City Oncological Hospital No.1, Moscow, Russian Federation info_outline Yana Gridneva, Alexander Sultanbaev, Yulia Anzhiganova, Mark Gluzman, Anastasia Mochalova, Alexey Shkurat, Elvira Parsadanova, Edgar Israelyan, Yulia Murzina, Aleksey Kalpinsky, Olesia Stativko, Elena Karabina, Artyom Kеln, Vladislav Petkau, Natalya Tovbik, Maria Turganova, Sufiia Safina, Evgeny Kopyltsov, Maria Volkova, Ilya Tsimafeyeu Organizations Moscow City Oncological Hospital No.1, Moscow, Russian Federation, Republican Clinical Oncology Dispensary, Ufa, Russian Federation, Krasnoyarsk Regional Clinical Oncological Dispensary Named After A.I. Kryzhanovsky, Krasnoyarsk, Russian Federation, Saint Petersburg State University, Saint Petersburg, Russian Federation, Clinical hospital #1, Medsi Otradnoe, Moscow, Russian Federation, SBHI Leningrad Regional Clinical Hospital, Saint-Petersburg, Russian Federation, Sakhalin Regional Clinical Oncology Dispensary, Yuzhno-Sakhalinsk, Russian Federation, N. N. Blokhin Russian Cancer Research Centre, Moscow, Russian Federation, Birobidzhan Regional Cancer Center, Birobidzhan, Russian Federation, P.A. Herzen Moscow Oncological Research Institute, Moscow, Russian Federation, Moscow City Clinical Oncology Hospital No. 1, Moscow, Russian Federation, Tula Regional Oncology Dispensary, Tula, Russian Federation, Tyumen State Medical University, Tyumen, Russian Federation, Sverdlovskiy Regional Oncological Dispensary, Ekaterinburg, Russian Federation, Amur Regional Oncology Center, Blagoveshchensk, Russian Federation, Novosibirsk Regional Cancer Center, Novosibirsk, Russian Federation, Republican Dispensary of Tatarstan, Kazan, Russian Federation, Omsk Regional Cancer Center, Omsk, Russian Federation, Bureau of Cancer Research - Moscow office, Moscow, Russian Federation Abstract Disclosures Research Funding Bureau for Cancer Research - BUCARE Background: The RAVE-Bladder study was designed to assess the efficacy and safety of avelumab maintenance in patients with metastatic urothelial carcinoma in a real-world population. Methods: In this non-interventional, ambispective study, eligible patients had metastatic urothelial carcinoma and measurable disease that had not progressed with first-line platinum-based chemotherapy. Patients received maintenance avelumab according to a standard regimen (800 mg, administered every 2 weeks). Tumor imaging was performed at baseline and then every 12 weeks. The primary endpoint was overall survival (OS) at the initiation of avelumab treatment, while secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Results: At data cutoff (February 02, 2024), 110 patients (81% male, 19% female) were recruited from 21 sites and median follow-up was 9.71 months. Median age was 65 (range, 36-84) years. All patients had confirmed urothelial carcinoma (high grade, 62.8%). Primary tumor site was upper urinary tract in 26 (23.6%) and bladder in 84 (76.4%) cases. Forty-five (40.9%) patients had radical surgery; 68 (61.8%) had metastatic disease at time of diagnosis; 44 (40%) had 2 and more metastatic sites. First-line chemotherapy included gemcitabine + cisplatin, gemcitabine + carboplatin, cisplatin only, carboplatin only, and MVAC in 51 (46.4%), 32 (29%), 19 (17.3%), 7 (6.4%), and 1 (0.9%) patients, respectively. Median number of chemotherapy cycles was 4 (range, 3-9) and median number of avelumab infusions was 16 (range, 2-43). ORR to chemotherapy was 48.2%. An additional 38 patients (34.6%) responded to avelumab therapy (16 CR, 22 PR). Median OS was not reached and 1-year OS rate was 78.7%. Median PFS was 9.5 months (95% CI 7.8 – 11.2 months). Thirteen (11.8%) patients experienced grade 3 adverse events during avelumab therapy. Conclusions: The findings illustrate the favorable tolerability of maintenance therapy with avelumab, a remarkable progression-free interval subsequent to standard platinum-containing chemotherapy and prominent additional response rate among patients with metastatic urothelial carcinoma. Ongoing follow-up continues to provide additional insights. Clinical trial information: KCRB01012022.

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