The AVION study, presented at the 2025 Genitourinary Cancers Symposium, provides real-world evidence supporting the efficacy and safety of first-line avelumab (Bavencio) plus axitinib (Inlyta) in patients with advanced renal cell carcinoma (RCC). The study's findings align with those of previous clinical trials, reinforcing the combination's role in treating this challenging malignancy.
AVION Study Details
The prospective, noninterventional AVION study enrolled patients from Belgium, Germany, Greece, and Russia who were receiving treatment for locally advanced, recurrent, or metastatic RCC. Patients had already received one or two doses of frontline avelumab plus axitinib and continued treatment with the combination during the study. The primary endpoint was the overall survival (OS) rate at 12 months.
Patients received avelumab intravenously at 800 mg every two weeks and axitinib orally at 5 mg twice daily. Key secondary endpoints included the 24-month OS rate, progression-free survival (PFS), objective response rate (ORR), and safety.
Survival and Response Rates
Data from the AVION study, with a cutoff date of July 5, 2024, showed promising survival outcomes. Among 104 patients who received the combination in routine clinical practice, the median OS was not reached. The 6-month OS rate was 89.1% (95% CI, 81.2%-93.8%), and the 12-month OS rate was 82.7% (95% CI, 73.5%-88.9%).
In the overall population, the median PFS was 11.3 months (95% CI, 8.1-NE). The 6- and 12-month PFS rates were 72.5% (95% CI, 62.1%-80.5%) and 48.4% (95% CI, 37.5%-58.5%), respectively. Among 87 response-evaluable patients, the ORR was 46.0% (95% CI, 35.2%-57.0%).
Subgroup Analysis
Subgroup analyses revealed consistent 12-month OS rates across different age groups: 85.5% for those younger than 65, 84.5% for those between 65 and 75, and 75.8% for those older than 75. Patients with an ECOG performance status of 0/1 had a 12-month OS rate of 84.3%, while those with a status of 2 had a rate of 57.1%.
Safety and Tolerability
The AVION study also provided valuable insights into the safety profile of the avelumab plus axitinib combination. Any-grade adverse events (AEs) were observed in 83.7% of patients, with grade 3 or higher AEs occurring in 34.6%. Treatment-related AEs (TRAEs) of any grade were reported in 67.3% of patients, and grade 3 or higher TRAEs in 20.2%.
The most common TRAEs included diarrhea (26.0%), fatigue (13.5%), and hypertension (10.6%). Discontinuation of avelumab or axitinib due to AEs occurred in 9.6% and 14.4% of patients, respectively. Serious AEs and serious TRAEs were noted in 36.5% and 14.4% of patients, respectively. Health-related quality of life (HRQOL) remained mostly stable throughout the study period.
JAVELIN Renal 101 Trial
These real-world findings are supported by the phase 3 JAVELIN Renal 101 trial, which demonstrated that first-line avelumab plus axitinib significantly prolonged progression-free survival (PFS) and increased objective response rates (ORRs) compared to sunitinib. The final analysis of JAVELIN Renal 101 showed a median PFS of 13.9 months with the combination versus 8.5 months with sunitinib (HR, 0.66; 95% CI, 0.566-0.769; P ≤ .0001). The ORRs were 59.7% and 32.0%, respectively (OR, 3.226; 95% CI, 2.406-4.279; P < .0001).
Clinical Implications
The AVION study reinforces the clinical utility of avelumab plus axitinib as a first-line treatment option for patients with advanced RCC. The real-world data confirm the efficacy and safety observed in clinical trials, providing clinicians with additional confidence in using this combination to improve outcomes for their patients. According to lead study author Axel Stuart Merseburger, MD, PhD, the results demonstrate the effectiveness, safety, favorable tolerability, and stable health-related quality of life of avelumab plus axitinib in a heterogeneous real-world population.
