Avelumab plus axitinib for first-line treatment of advanced renal cell carcinoma: A real-world ambispective RAVE-Renal study.
Methods: Patients were recruited from 13 sites, with data collected anonymously online. Key inclusion criteria were untreated mRCC and a minimum age of 18 years. Safety and efficacy assessments were conducted in all patients who received at least one dose of avelumab and axitinib. The primary endpoints included ORR and PFS, while secondary endpoints encompassed overall survival (OS) and the incidence of treatment-related adverse events (TRAEs).
Results: At the time of data cutoff (February 03, 2024), a total of 125 patients were enrolled and treated. Median age was 61 years (range, 37-74). Patients were predominantly men (74.3%), previously nephrectomised (81.4%), had 2 and more metastatic sites (77.1%) including bone (24.3%), liver (15.7%), and brain (3%) metastases. IMDC risk was evaluated in 102 patients. Among these patients, 36 (35.3%) were categorized as having favorable risk, 50 (49%) as intermediate risk, and 16 (15.7%) as poor risk. The median number of avelumab infusions was 7 (range, 1-29). Table summarizes efficacy and safety data.
Conclusions: The real-world study of first-line avelumab and axitinib therapy reveals comparable ORR and PFS to those observed in the pivotal clinical trial among patients with mRCC. The combination was well tolerated. Further follow-up of patients in the study is ongoing. Clinical trial information: KCRB01012022.
Viacheslav Chubenko, Olga Baklanova, Alexey Kalpinskiy, Sufiia Safina, Andrey Lebedinets, Alexey Shkurat, Elvira Parsadanova, Maria Turganova, Vladislav Petkau, Natalya Tovbik, Elena Tkacheva, Yulia Anzhiganova, Olga Novikova, Varvara Bragina, Ruslan Zukov, and Ilya Tsimafeyeu
St. Petersburg Clinical and Research Center of Specialized Types of Oncological Medical Care, St. Petersburg, Russian Federation; Irkutsk Regional Cancer Center, Irkutsk, Russian Federation; P.A. Hertsen Moscow Oncology Research Center - National Medical Research Center of Radiology, Moscow, Russian Federation; Republican Dispensary of Tatarstan, Kazan, Russian Federation; SBHI Leningrad Regional Clinical Hospital, Saint-Petersburg, Russian Federation; SBHI Leningrad Regional Clinical Hospital, Saint-Petersburg, Russian Federation; Sakhalin Regional Clinical Oncology Dispensary, Yuzhno-Sakhalinsk, Russian Federation; Novosibirsk Regional Cancer Center, Novosibirsk, Russian Federation; Sverdlovskiy Regional Oncological Dispensary, Ekaterinburg, Russian Federation; Amur Regional Oncology Center, Blagoveshchensk, Russian Federation; Primorsky Regional Cancer Center, Vladivostok, Russian Federation; A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center, Krasnoyarsk, Russian Federation; Khabarovsk Regional Cancer Center, Khabarovsk, Russian Federation; Tver Regional Cancer Center, Tver, Russian Federation; V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russian Federation; Bureau of Cancer Research - Moscow office, Moscow, Russian Federation.
Source: Viacheslav Chubenko, Olga Baklanova, Alexey Kalpinskiy et al. Avelumab plus axitinib for first-line treatment of advanced renal cell carcinoma: A real-world ambispective RAVE-Renal study. Journal of Clinical Oncology. 2024. Volume 42, Number 23_suppl. https://doi.org/10.1200/JCO.2024.42.23_suppl.117
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