REAL-WORLD EFFECTIVENESS AND SAFETY OF FIRST-LINE (1L) AVELUMAB + AXITINIB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC): PRIMARY ANALYSIS OF THE AVION STUDY

INTRODUCTION: In the JAVELIN Renal 101 phase 3 trial, 1L avelumab + axitinib resulted in significantly longer progression-free survival (PFS) and a higher objective response rate (ORR) vs sunitinib in patients with advanced RCC. Real-world studies are needed. METHODS: AVION is a prospective noninterventional study of patients with advanced RCC receiving 1L avelumab + axitinib in Germany, Greece, Belgium, and Russia. The primary endpoint is 12-month overall survival (OS) rate. Patients are observed for 24 months. PURPOSE: We report the primary analysis of AVION. RESULTS: 104 patients were analyzed. International Metastatic RCC Database Consortium risk was favorable, intermediate, poor, or unreported in 26.0%, 45.2%, 12.5%, and 16.3%, respectively. Tumor histology was clear cell, sarcomatoid, or other in 89.4%, 3.8%, and 6.7%, respectively. Prior treatment included adjuvant drug treatment, surgery (nephrectomy), or radiotherapy in 3.8%, 75.0% (66.3%), and 8.7%, respectively. At data cutoff (July 2024), avelumab or axitinib treatment was ongoing in 20.0%. Median OS was not reached (95% CI, not estimable [NE]) and 12-month OS rate was 82.7% (95% CI, 73.5-88.9). Median PFS (95% CI) was 11.3 months (8.1-NE) and 6- and 12-month PFS rates (95% CI) were 72.5% (62.1-80.5) and 48.4% (37.5-58.5), respectively. In 87 patients with response data, ORR (assessed up to 12 months) was 46.0% (95% CI, 35.2-57.0; complete response in 4.6%) and median duration of response was not reached. Treatment-related adverse events (TRAEs) occurred in 67.3% and were grade ≥3 in 20.2%. TRAEs led to permanent discontinuation of avelumab or axitinib in 6.7% or 9.6%, respectively, and led to death in 1.0%. The most common TRAEs (any grade) were diarrhea (19.2%), fatigue (13.5%), and hypothyroidism (8.7%). CONCLUSION: Results from AVION are generally consistent with JAVELIN Renal 101 and previous observational studies, demonstrating the effectiveness and tolerability of avelumab + axitinib in a heterogeneous real-world population.