Real-world effectiveness and safety of first-line (1L) avelumab + axitinib in patients with advanced renal cell carcinoma (aRCC): Primary analysis of the AVION study.

474 Background: 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 aRCC, with an acceptable safety profile. The AVION study is evaluating the effectiveness and safety of avelumab + axitinib in routine clinical practice in various countries. We report data from the primary analysis. Methods: AVION is a prospective noninterventional study of patients with aRCC receiving 1L avelumab + axitinib in Germany, Greece, Belgium, or Russia. Patients are observed for 24 months. The primary objective is to evaluate the overall survival (OS) rate at 12 months. Secondary objectives include evaluation of OS rate at 24 months, median OS, PFS, ORR, duration of response (DOR), and safety. Results: By data cutoff (Jul 5, 2024), 104 patients were analyzed. Median age was 70 years (range, 37-87) and 70.2% were male. ECOG PS was 0-1 in 92.3%, 2 in 6.7%, and not reported (NR) in 1.0%. International Metastatic RCC Database Consortium (IMDC) risk group was favorable, intermediate, poor, and NR in 26.0%, 45.2%, 12.5%, and 16.3%, respectively. Tumor histology was clear cell, sarcomatoid, and other in 89.4%, 3.8%, and 6.7%, respectively. Prior anticancer treatment included adjuvant drug treatment, surgery (nephrectomy), or radiotherapy in 3.8%, 75.0% (66.3%), and 8.7%, respectively. At data cutoff, avelumab or axitinib treatment was ongoing in 21 (20.0%). Median OS was not reached (95% CI, not estimable [NE]) and the 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. Among 87 patients with available response data (assessed up to 12 months), ORR was 46.0% (95% CI, 35.2-57.0), comprising complete or partial response in 4.6% and 41.4%, respectively; disease control rate was 79.3% (95% CI, 69.3-87.3); and median DOR was not reached. Treatment-related adverse events (TRAEs) occurred in 67.3% and were grade ≥3 or serious in 20.2% and 14.4%, respectively. 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 of any grade (≥6%) were diarrhea (19.2%), fatigue (13.5%), hypothyroidism (8.7%), and nausea (7.7%). Follow-up is ongoing. Conclusions: Results from the AVION study are generally consistent with JAVELIN Renal 101 and previous observational studies, demonstrating the effectiveness, safety, and favorable tolerability with low discontinuation rates of avelumab + axitinib in a heterogeneous real-world population.