Кабозантиниб в лечении пациентов с распространенным почечно-клеточным раком

Волкова М.И., Турупаев К.А., Нерсесова Т.А., Заславская К.Я. Кабозантиниб в лечении пациентов с распространенным почечно-клеточным раком. Современная Онкология. 2025;27(3):258–266. DOI: 10.26442/18151434.2025.3.203335

© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.

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Volkova MI, Turupaev KA, Nersesova TA, Zaslavskaya KYa. Cabozantinib in the treatment of patients with advanced renal cell carcinoma: A review. Journal of Modern Oncology. 2025;27(3):258–266. DOI: 10.26442/18151434.2025.3.203335

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Аннотация

Стратегия лечения больных местно-распространенным и диссеминированным почечно-клеточным раком (ПКР) за последние 10 лет претерпела существенные изменения. Появление эффективных ингибиторов контрольных точек противоопухолевого иммунного ответа и высокоаффинных мультикиназных ингибиторов II поколения, внедрение факторов прогноза для персонификации лечения, а также оптимизация последовательности и комбинаций режимов лекарственной терапии позволили существенно увеличить показатели выживаемости пациентов с распространенными формами ПКР. Кабозантиниб является одним из высокоаффинных мультикиназных ингибиторов II поколения с доказанной противоопухолевой активностью и безопасностью у пациентов с распространенными формами ПКР. Результаты регистрационных исследований способствовали включению кабозантиниба как в режиме монотерапии, так и в комбинации с ниволумабом в международные и отечественные клинические рекомендации по лечению больных ПКР по широкому спектру показаний. Появление препарата КАБОЗАНТИНИБ-ПРОМОМЕД на отечественном рынке расширяет доступ к использованию данной лечебной опции для больных ПКР. В статье представлены результаты клинических исследований кабозантиниба при местно-распространенном и диссеминированном ПКР, а также испытаний биоэквивалентности препарата КАБОЗАНТИНИБ-ПРОМОМЕД.

Ключевые слова: почечно-клеточный рак, кабозантиниб, ниволумаб, иммунотаргетная терапия, безопасность, эффективность

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The treatment strategy for patients with locally advanced and disseminated renal cell carcinoma (RCC) has undergone significant changes over the past 10 years. The emergence of effective antitumor immune response checkpoint inhibitors and high-affinity multikinase inhibitors of the second generation, the introduction of prognostic factors to personalize treatment, as well as the optimization of the sequence and combinations of drug regimens, have significantly increased the survival rates of patients with advanced RCC. Cabozantinib is one of the high-affinity multikinase inhibitors of the second generation with proven antitumor activity and safety in patients with advanced RCC. The results of registration studies contributed to the introduction of cabozantinib, both as monotherapy and in combination with nivolumab, into international and Russian clinical guidelines for the treatment of RCC patients across a wide range of indications. The launch of Cabozantinib-Promomed on the Russian market expands access to this treatment option for patients with RCC. The article presents the results of clinical studies of cabozantinib in patients with locally advanced and disseminated RCC, as well as bioequivalence studies of Cabozantinib.

Keywords: renal cell carcinoma, cabozantinib, nivolumab, immune targeting therapy, safety, effectiveness

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Список литературы

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15. Martínez Chanzá N, Xie W, Asim Bilen M, et al. Cabozantinib in advanced non-clear-cell renal cell carcinoma: A multicentre, retrospective, cohort study. Lancet Oncol. 2019;20(4):581-90. DOI:10.1016/S1470-2045(18)30907-0
16. Barata P, Tangen C, Plets M, et al. Final overall survival analysis of S1500: A randomized, phase ii study comparing sunitinib with cabozantinib, crizotinib, and savolitinib in advanced papillary renal cell carcinoma. J Clin Oncol. 2024;42(33):3911-6. DOI:10.1200/JCO.24.00767
17. Pal SK, Tangen C, Thompson IM Jr, et al. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: A randomised, open-label, phase 2 trial. Lancet. 2021;397(10275):695-703. DOI:10.1016/S0140-6736(21)00152-5
18. Fitzgerald KN, Lee CH, Voss MH, et al. Cabozantinib plus nivolumab in patients with non-clear cell renal cell carcinoma: Updated results from a phase 2 trial. Eur Urol. 2024;86(2):90-4. DOI:10.1016/j.eururo.2024.04.025. Corrigendum to: Eur Urol. 2025;87(1):96. DOI:10.1016/j.eururo.2024.10.002
19. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): Final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016;17(7):917-27. DOI:10.1016/S1470-2045(16)30107-3
20. Santoni M, Massari F, Bracarda S, et al. Cabozantinib in patients with advanced renal cell carcinoma primary refractory to first-line immunocombinations or tyrosine kinase inhibitors. Eur Urol Focus. 2022;8(6):1696-702. DOI:10.1016/j.euf.2022.02.004
21. Vano YA, Phan L, Gravis G, et al. Cabozantinib-nivolumab sequence in metastatic renal cell carcinoma: The CABIR study. Int J Cancer. 2022;151(8):1335-44. DOI:10.1002/ijc.34126
22. Venugopal B, Pillai M, Powles T, et al. Early clinical experience with cabozantinib for advanced renal cell carcinoma in the UK: Real-world treatment pathways and clinical outcomes. Clin Genitourin Cancer. 2022;20(1):94-94.e10. DOI:10.1016/j.clgc.2021.09.005
23. Richter I, Poprach A, Zemankova A, et al. Patients with metastatic renal cell carcinoma treated with cabozantinib in the Czech Republic: Analysis of four cancer centers. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022;166(1):97-104. DOI:10.5507/bp.2020.055
24. Gross-Goupil M, Bodnar L, Campbell MT, et al. Cabozantinib in the routine management of renal cell carcinoma: A systematic literature review of real-world evidence gross-goupil. Clin Genitourin Cancer. 2024;22(1):84-97. DOI:10.1016/j.clgc.2023.11.001
25. Marteau F, Harrow B, McCarthy C, et al. Cabozantinib versus other TKIs after CPI treatment in the real-world management of patients with metastatic renal cell carcinoma (mRCC). JCO. 2021;39(Suppl. 15):239. DOI:10.1200/JCO.2021.39.6_suppl.293
26. Grünwald V, Martin B, Mohammad-Reza R, et al. Final analysis of a non-interventional study on cabozantinib in patients with advanced renal cell carcinoma after prior checkpoint inhibitor therapy (CaboCHECK). JCO. 2022;40(Suppl. 15):357. DOI:10.1200/JCO.2022.40.6_suppl.357
27. Albiges L. CaboPoint: Final results from a phase 2 study of cabozantinib after checkpoint inhibitor combinations in patients with advanced renal cell carcinoma, ESMO 2024, Barcelona, Spain. Available at: https://www.urotoday.com/conference-highlights/esmo-2024/esmo-2024-kidney-cancer/154773-esmo-2024-ca.... Accessed: 05.06.2025.
28. Laccetti AL, Garmezy B, Xiao L, et al. Combination antiangiogenic tyrosine kinase inhibition and anti-PD1 immunotherapy in metastatic renal cell carcinoma: A retrospective analysis of safety, tolerance, and clinical outcomes. Cancer Med. 2021;10(7):2341-9. DOI:10.1002/cam4.3812
29. Negrier S, Mourey L, Blanc E, et al. Cabozantinib in patients (pts) with non-locally pretreated brain metastases (BM) from renal cell carcinoma (RCC): Results of the multicenter CABRAMET phase II trial (NCT03967522). J Clin Oncol. 2025;43(Suppl. 5; abstr 533). DOI:10.1200/jco.2025.43.5_suppl.533
30. GRLSBASE. РКИ №361 от 09.07.2021 №KAB-032021. Режим доступа: https://grlsbase.ru/clinicaltrails/clintrail/11567. Ссылка активна на 05.03.2025 [GRLSBASE. RKI No.361 ot 09.07.2021 No.KAB-032021. Available at: https://grlsbase.ru/clinicaltrails/clintrail/11567. Accessed: 05.03.2025 (in Russian)].

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1. Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009;27(34):5794-9. DOI:10.1200/JCO.2008.21.4809
2. Volkova MI, Nosov DA, Alekseev BIa, et al. Pochechnokletochnyi rak. Prakticheskie rekomendatsii RUSSCO, chast' 1.2. Malignant Tumors. 2024;14(3s2):207-20 (in Russian). DOI:10.18027/2224-5057-2024-14-3s2-1.2-08
3. Kidney Cancer, Version 3.2025, NCCN Clinical Practice Guidelines in Oncology. Available at: https://www.nccn.org/guidelines/nccn-guidelines. Accessed: 05.06.2025.
4. EAU Guidelines. Edn. presented at the EAU Annual Congress Madrid, Spain 2025. Available at: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-Guidelines-on-Primary-Urethral-Car.... Accessed: 05.06.2025.
5. Volkova MI, Poddubnaia IV, Turupaev KA, Trofimova OP. Korrektsiia nezhelatel'nykh iavlenii, razvivshikhsia na fone targetnoi terapii tirozinkinaznymi ingibitorami u bol'nykh rasprostranennym rakom pochki. Moscow, 2022 (in Russian).
6. Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021;384(9):829-41. DOI:10.1056/NEJMoa2026982
7. Motzer R. Nivolumab plus cabozantinib vs sunitinib for previously untreated advanced renal cell carcinoma: Final follow-up results from the CheckMate 9ER Trial. Genitourinary (GU) American Society of Clinical Oncology (ASCO) annual meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025. Available at: https://www.urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-kidney-cancer/158352-asco-g.... Accessed: 05.06.2025.
8. Cella D, Motzer RJ, Suarez C, et al. Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: An open-label, randomised, phase 3 trial. Lancet Oncol. 2022;23(2):292-303. DOI:10.1016/S1470-2045(21)00693-8
9. Hilser T, Darr C, Niegisch G, et al. Cabozantinib plus nivolumab in adult patients with advanced or metastatic renal cell carcinoma: A retrospective, non-interventional study in a real-world cohort/GUARDIANS Project. Cancers (Basel). 2024;16(17):2998. DOI:10.3390/cancers16172998
10. Motzer RJ, Choueiri TK, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. J Clin Oncol. 2021;39(Suppl. 6):308. DOI:10.1200/JCO.2021.39.6_suppl.308
11. Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115-25. DOI:10.1016/j.ejca.2018.02.012. Corrigendum to: Eur J Cancer. 2018;103:287. DOI:10.1016/j.ejca.2018.09.022
12. Gan CL, Dudani S, Wells JC, et al. Cabozantinib real-world effectiveness in the first-through fourth-line settings for the treatment of metastatic renal cell carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium. Cancer Med. 2021;10(4):1212-21. DOI:10.1002/cam4.3717
13. Volkova MI, Kalpinskiy AS, Men’shikov KV, et al. Efficacy and safety of cabozantinib in metastatic renal cell carcinoma patients: Russian multicenter observational study. Onkourolog iya = Cancer Urology. 2023;19(1):46-60 (in Russian). DOI:10.17650/1726-9776-2023-19-1-46-60
14. Campbell MT, Bilen MA, Shah AY, et al. Cabozantinib for the treatment of patients with metastatic non-clear cell renal cell carcinoma: A retrospective analysis. Eur J Cancer. 2018;104:188-94. DOI:10.1016/j.ejca.2018.08.014
15. Martínez Chanzá N, Xie W, Asim Bilen M, et al. Cabozantinib in advanced non-clear-cell renal cell carcinoma: A multicentre, retrospective, cohort study. Lancet Oncol. 2019;20(4):581-90. DOI:10.1016/S1470-2045(18)30907-0
16. Barata P, Tangen C, Plets M, et al. Final overall survival analysis of S1500: A randomized, phase ii study comparing sunitinib with cabozantinib, crizotinib, and savolitinib in advanced papillary renal cell carcinoma. J Clin Oncol. 2024;42(33):3911-6. DOI:10.1200/JCO.24.00767
17. Pal SK, Tangen C, Thompson IM Jr, et al. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: A randomised, open-label, phase 2 trial. Lancet. 2021;397(10275):695-703. DOI:10.1016/S0140-6736(21)00152-5
18. Fitzgerald KN, Lee CH, Voss MH, et al. Cabozantinib plus nivolumab in patients with non-clear cell renal cell carcinoma: Updated results from a phase 2 trial. Eur Urol. 2024;86(2):90-4. DOI:10.1016/j.eururo.2024.04.025. Corrigendum to: Eur Urol. 2025;87(1):96. DOI:10.1016/j.eururo.2024.10.002
19. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): Final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016;17(7):917-27. DOI:10.1016/S1470-2045(16)30107-3
20. Santoni M, Massari F, Bracarda S, et al. Cabozantinib in patients with advanced renal cell carcinoma primary refractory to first-line immunocombinations or tyrosine kinase inhibitors. Eur Urol Focus. 2022;8(6):1696-702. DOI:10.1016/j.euf.2022.02.004
21. Vano YA, Phan L, Gravis G, et al. Cabozantinib-nivolumab sequence in metastatic renal cell carcinoma: The CABIR study. Int J Cancer. 2022;151(8):1335-44. DOI:10.1002/ijc.34126
22. Venugopal B, Pillai M, Powles T, et al. Early clinical experience with cabozantinib for advanced renal cell carcinoma in the UK: Real-world treatment pathways and clinical outcomes. Clin Genitourin Cancer. 2022;20(1):94-94.e10. DOI:10.1016/j.clgc.2021.09.005
23. Richter I, Poprach A, Zemankova A, et al. Patients with metastatic renal cell carcinoma treated with cabozantinib in the Czech Republic: Analysis of four cancer centers. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022;166(1):97-104. DOI:10.5507/bp.2020.055
24. Gross-Goupil M, Bodnar L, Campbell MT, et al. Cabozantinib in the routine management of renal cell carcinoma: A systematic literature review of real-world evidence gross-goupil. Clin Genitourin Cancer. 2024;22(1):84-97. DOI:10.1016/j.clgc.2023.11.001
25. Marteau F, Harrow B, McCarthy C, et al. Cabozantinib versus other TKIs after CPI treatment in the real-world management of patients with metastatic renal cell carcinoma (mRCC). JCO. 2021;39(Suppl. 15):239. DOI:10.1200/JCO.2021.39.6_suppl.293
26. Grünwald V, Martin B, Mohammad-Reza R, et al. Final analysis of a non-interventional study on cabozantinib in patients with advanced renal cell carcinoma after prior checkpoint inhibitor therapy (CaboCHECK). JCO. 2022;40(Suppl. 15):357. DOI:10.1200/JCO.2022.40.6_suppl.357
27. Albiges L. CaboPoint: Final results from a phase 2 study of cabozantinib after checkpoint inhibitor combinations in patients with advanced renal cell carcinoma, ESMO 2024, Barcelona, Spain. Available at: https://www.urotoday.com/conference-highlights/esmo-2024/esmo-2024-kidney-cancer/154773-esmo-2024-ca.... Accessed: 05.06.2025.
28. Laccetti AL, Garmezy B, Xiao L, et al. Combination antiangiogenic tyrosine kinase inhibition and anti-PD1 immunotherapy in metastatic renal cell carcinoma: A retrospective analysis of safety, tolerance, and clinical outcomes. Cancer Med. 2021;10(7):2341-9. DOI:10.1002/cam4.3812
29. Negrier S, Mourey L, Blanc E, et al. Cabozantinib in patients (pts) with non-locally pretreated brain metastases (BM) from renal cell carcinoma (RCC): Results of the multicenter CABRAMET phase II trial (NCT03967522). J Clin Oncol. 2025;43(Suppl. 5; abstr 533). DOI:10.1200/jco.2025.43.5_suppl.533
30. GRLSBASE. RKI No.361 ot 09.07.2021 No.KAB-032021. Available at: https://grlsbase.ru/clinicaltrails/clintrail/11567. Accessed: 05.03.2025 (in Russian).

Авторы

М.И. Волкова*^1,2, К.А. Турупаев³, Т.А. Нерсесова¹, К.Я. Заславская⁴

¹Онкологический центр №1 ГБУЗ г. Москвы «Городская клиническая больница им. С.С. Юдина Департамента здравоохранения г. Москвы», Москва, Россия;
²ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
³ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия;
⁴ФГБОУ ВО «Национальный исследовательский Мордовский государственный университет им. Н.П. Огарева», Саранск, Россия
*mivolkova@rambler.ru

________________________________________________

Maria I. Volkova*^1,2, Kirill A. Turupaev³, Tatiana A. Nersesova¹, Kira Ya. Zaslavskaya⁴

¹Moscow State Budgetary Healthcare Institution «Oncological Center No. 1 of Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department», Moscow, Russia;
²Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
³Blokhin National Medical Research Center of Oncology, Moscow, Russia;
⁴National Research Ogarev Mordovian State University, Saransk, Russia
*mivolkova@rambler.ru

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