Efficacy of avelumab and axitinib depending on disease burden in patients with metastatic renal cell carcinoma: a subgroup analysis of the RAVE-Renal trial

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Abstract

Background. Immunotherapies and targeted therapies have demonstrated significant efficacy in prospective randomized trials establishing them as the standard of care for patients with metastatic renal cell carcinoma.

This analysis, part of the RAVE-Renal real-world study, aimed to evaluate the effectiveness of avelumab plus axitinib based on disease burden and the presence of liver and bone metastases.

Materials and methods. The RAVE-Renal trial was a multicenter, ambispective study that included treatment-naïve patients with histologically confirmed metastatic renal cell carcinoma and measurable lesions. Patients were treated with avelumab (800 mg every two weeks) and axitinib (5 mg twice daily). Primary endpoints were median progressionfree survival (PFS) and objective response rate (ORR). Secondary endpoints included median overall survival, 1-year overall survival, and safety. Subgroup analyses evaluated median PFS and ORR in patients with ³2 organ metastases, bone metastases, and liver metastases.

Results. A total of 125 patients from 13 centers were enrolled, with median follow-up of 16.1 months and median age of 61 years. Based on IMDC (International Metastatic RCC Database Consortium) risk categories, 35.3 % had favorable, 49 % had intermediate, and 15.7 % had poor prognosis. The overall population demonstrated median PFS of 14.9 months and ORR of 44.3 %. Among patients with ³2 organ metastases, median PFS was 13.0 months, and ORR was 36.7 % (all p >0.05). In those with bone metastases, median PFS was 6.5 months (p = 0.160), and ORR was 23.5 % (p = 0.0148). For patients with liver metastases, median PFS was 17.6 months, and ORR was 45.5 % (all p >0.05).

Conclusion. The combination of avelumab and axitinib demonstrated consistent efficacy in patients with advanced disease including those with liver and bone metastases. These findings suggest the regimen’s broad applicability and suitability in real-world clinical practice.

About the authors

V. A. Chubenko

Saint-Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

ORCID iD: 0000-0001-6644-6687

Lit. A, 68A Leningradskaya St., Pesochnyy, Saint Petersburg 197758

Russian Federation

O. V. Baklanova

Regional Oncology Dispensary

ORCID iD: 0000-0002-2331-506X

32 Frunze St., Irkutsk 664035

Russian Federation

A. S. Kalpinskiy

P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia

ORCID iD: 0000-0002-2209-3020

3 2nd Botkinskiy Proezd, Moscow 125284

Russian Federation

S. Z. Safina

Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after prof. M.Z. Sigal

ORCID iD: 0000-0002-5309-8406

29 Sibirskiy Trakt St., Kazan 420029

Russian Federation

A. A. Lebedinets

Leningrad Regional Clinical Hospital

ORCID iD: 0009-0002-0240-6656

Lit. A, Build. 2, 45 Lunacharskogo Prospekt, Saint-Petersburg 194291

Russian Federation

V. V. Petkau

Ural State Medical University, Ministry of Health of Russia

ORCID iD: 0000-0002-0342-4007

3 Repina St., Yekaterinburg 620028

Russian Federation

E. L. Parsadanova

Sakhalin Regional Clinical Oncology Dispensary

ORCID iD: 0009-0001-5470-0219

3 Gor’kogo St., Yuzhno-Sakhalinsk 693010

Russian Federation

Yu. V. Anzhiganova

A.I. Kryzhanovsky Krasnoyarsk Regional Clinical Oncology Dispensary

ORCID iD: 0000-0002-8388-466X

16 1-ya Smolenskaya St., Krasnoyarsk 660133

Russian Federation

O. Yu. Novikova

Regional Clinical Oncology Center, Ministry of Health of Khabarovsk Krai

ORCID iD: 0000-0002-0950-0648

164 Voronezhskoe Shosse, Khabarovsk 680042

Russian Federation

V. S. Bragina

Tver Regional Clinical Oncology Dispensary

57/37 15 Let Oktyabrya St., Tver 170008

Russian Federation

E. V. Tkacheva

Primorsky Regional Oncology Dispensary

59 Russkaya St., Vladivostok 690105

Russian Federation

A. O. Shkurat

Leningrad Regional Clinical Hospital

ORCID iD: 0000-0003-0776-724X

Lit. A, Build. 2, 45 Lunacharskogo Prospekt, Saint-Petersburg 194291

Russian Federation

M. I. Gluzman

Saint Petersburg State University

ORCID iD: 0000-0002-8965-8364

7–9 Universitetskaya Naberezhnaya, Saint Petersburg 199034

Russian Federation

R. A. Zukov

A.I. Kryzhanovsky Krasnoyarsk Regional Clinical Oncology Dispensary;
V.F. Voyno-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia

ORCID iD: 0000-0002-7210-3020

16 1-ya Smolenskaya St., Krasnoyarsk 660133; 
1 Partizana Zheleznyaka St., Krasnoyarsk 660022

Russian Federation

I. V. Tsimafeyeu

Bureau for Cancer Research

Author for correspondence.
Email: tsimafeyeu@gmail.com
ORCID iD: 0000-0002-7357-0392

Ilya Valer’evich Tsimafeyeu

2 Mayakovskogo Pereulok, Moscow 109147

Russian Federation

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