Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study
Background: The RAVE-Renal study was conducted to evaluate the real-world efficacy and safety of avelumab plus axitinib as a first-line therapy for patients with metastatic renal cell carcinoma (mRCC). Methods: RAVE-Renal was a multicenter, noninterventional, ambispective study with both retrospecti...
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MDPI AG
2024-12-01
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| Series: | Current Oncology |
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| Online Access: | https://www.mdpi.com/1718-7729/32/1/11 |
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| author | Ilya Tsimafeyeu Vyacheslav Chubenko Olga Baklanova Alexey Kalpinskiy Sufia Safina Andrei Lebedinets Vladislav Petkau Elvira Parsadanova Maria Turganova Aleksei Shkurat Natalia Tovbik Elena Tkacheva Yulia Anzhiganova Olga Novikova Varvara Bragina Ruslan Zukov Rashida Orlova |
| author_facet | Ilya Tsimafeyeu Vyacheslav Chubenko Olga Baklanova Alexey Kalpinskiy Sufia Safina Andrei Lebedinets Vladislav Petkau Elvira Parsadanova Maria Turganova Aleksei Shkurat Natalia Tovbik Elena Tkacheva Yulia Anzhiganova Olga Novikova Varvara Bragina Ruslan Zukov Rashida Orlova |
| author_sort | Ilya Tsimafeyeu |
| collection | DOAJ |
| description | Background: The RAVE-Renal study was conducted to evaluate the real-world efficacy and safety of avelumab plus axitinib as a first-line therapy for patients with metastatic renal cell carcinoma (mRCC). Methods: RAVE-Renal was a multicenter, noninterventional, ambispective study with both retrospective and prospective components. The study included adult patients with histologically confirmed mRCC, measurable disease per RECIST version 1.1, and no prior systemic therapy. Patients received avelumab (800 mg intravenously every 2 weeks) plus axitinib (5 mg orally twice daily). The primary endpoints were median progression-free survival (PFS) and objective response rate (ORR). The secondary endpoints included median OS, 1-year overall survival (OS) rate, and safety. Results: A total of 125 patients from 13 sites were enrolled, with a median follow-up of 16.1 months. The median age was 61.0 years. The study population comprised 35.3% favorable, 49% intermediate, and 15.7% poor IMDC risk patients. The median PFS was 14.9 months (95% CI, 11.72–19.08). The ORR was 44.3% (95% CI, 32.5–56.1). The clinical benefit rate was 93.4%. The 1-year OS rate was 71.2%, with the median OS not reached. Any-grade treatment-related adverse events (TRAEs) occurred in 99 (79.2%) cases, including grade ≥3 TRAEs in 24 (19.2%). Conclusions: Avelumab in combination with axitinib showed clinical benefits in a real-world setting, consistent with findings from a pivotal trial. The regimen was effective and well tolerated across various patient subgroups. |
| format | Article |
| id | doaj-art-7ecd1bd6e5b545dc8c096c9e48ae78ec |
| institution | Kabale University |
| issn | 1198-0052 1718-7729 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj-art-7ecd1bd6e5b545dc8c096c9e48ae78ec2025-01-24T13:28:21ZengMDPI AGCurrent Oncology1198-00521718-77292024-12-013211110.3390/curroncol32010011Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal StudyIlya Tsimafeyeu0Vyacheslav Chubenko1Olga Baklanova2Alexey Kalpinskiy3Sufia Safina4Andrei Lebedinets5Vladislav Petkau6Elvira Parsadanova7Maria Turganova8Aleksei Shkurat9Natalia Tovbik10Elena Tkacheva11Yulia Anzhiganova12Olga Novikova13Varvara Bragina14Ruslan Zukov15Rashida Orlova16Bureau for Cancer Research—BUCARE, Moscow Office, 125047 Moscow, RussiaSaint-Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care Oncological, 197110 Saint-Petersburg, RussiaIrkutsk Regional Cancer Center, 664048 Irkutsk, RussiaP.A. Hertsen Moscow Oncology Research Center—National Medical Research Center of Radiology, 125284 Moscow, RussiaRepublican Dispensary of Tatarstan, 420029 Kazan, RussiaSBHI Leningrad Regional Clinical Hospital, 194291 Saint-Petersburg, RussiaSverdlovskiy Regional Oncological Dispensary, 620036 Ekaterinburg, RussiaSakhalin Regional Cancer Center, 693010 Yuzhno-Sakhalinsk, RussiaNovosibirsk Regional Cancer Center, 630108 Novosibirsk, RussiaSBHI Leningrad Regional Clinical Hospital, 194291 Saint-Petersburg, RussiaAmursky Regional Cancer Center, 675006 Blagoveshchensk, RussiaPrimorsky Regional Cancer Center, 690091 Vladivostok, RussiaA.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center, 660133 Krasnoyarsk, RussiaKhabarovsk Regional Cancer Center, 680042 Khabarovsk, RussiaTver Regional Cancer Center, 170100 Tver, RussiaV.F. Voyno-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, RussiaSaint-Petersburg State University, 199034 Saint-Petersburg, RussiaBackground: The RAVE-Renal study was conducted to evaluate the real-world efficacy and safety of avelumab plus axitinib as a first-line therapy for patients with metastatic renal cell carcinoma (mRCC). Methods: RAVE-Renal was a multicenter, noninterventional, ambispective study with both retrospective and prospective components. The study included adult patients with histologically confirmed mRCC, measurable disease per RECIST version 1.1, and no prior systemic therapy. Patients received avelumab (800 mg intravenously every 2 weeks) plus axitinib (5 mg orally twice daily). The primary endpoints were median progression-free survival (PFS) and objective response rate (ORR). The secondary endpoints included median OS, 1-year overall survival (OS) rate, and safety. Results: A total of 125 patients from 13 sites were enrolled, with a median follow-up of 16.1 months. The median age was 61.0 years. The study population comprised 35.3% favorable, 49% intermediate, and 15.7% poor IMDC risk patients. The median PFS was 14.9 months (95% CI, 11.72–19.08). The ORR was 44.3% (95% CI, 32.5–56.1). The clinical benefit rate was 93.4%. The 1-year OS rate was 71.2%, with the median OS not reached. Any-grade treatment-related adverse events (TRAEs) occurred in 99 (79.2%) cases, including grade ≥3 TRAEs in 24 (19.2%). Conclusions: Avelumab in combination with axitinib showed clinical benefits in a real-world setting, consistent with findings from a pivotal trial. The regimen was effective and well tolerated across various patient subgroups.https://www.mdpi.com/1718-7729/32/1/11avelumab plus axitinibfirst-line therapymetastatic renal cell carcinomaRAVE-Renal ambispective study |
| spellingShingle | Ilya Tsimafeyeu Vyacheslav Chubenko Olga Baklanova Alexey Kalpinskiy Sufia Safina Andrei Lebedinets Vladislav Petkau Elvira Parsadanova Maria Turganova Aleksei Shkurat Natalia Tovbik Elena Tkacheva Yulia Anzhiganova Olga Novikova Varvara Bragina Ruslan Zukov Rashida Orlova Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study Current Oncology avelumab plus axitinib first-line therapy metastatic renal cell carcinoma RAVE-Renal ambispective study |
| title | Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study |
| title_full | Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study |
| title_fullStr | Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study |
| title_full_unstemmed | Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study |
| title_short | Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study |
| title_sort | real world efficacy and safety of avelumab plus axitinib in metastatic renal cell carcinoma results from the ambispective rave renal study |
| topic | avelumab plus axitinib first-line therapy metastatic renal cell carcinoma RAVE-Renal ambispective study |
| url | https://www.mdpi.com/1718-7729/32/1/11 |
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