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

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.