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

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438 Background: In the JAVELIN Renal 101 phase 3 trial, 1L Ave + Axi significantly prolonged progression-free survival (PFS) and increased the objective response rate (ORR) vs sunitinib in patients with aRCC, with an acceptable safety profile. At the final analysis, the 12- and 24-month overall survival (OS) rates for Ave + Axi were 85.7% and 68.8%, respectively. The AVION study evaluated patients with aRCC receiving 1L Ave + Axi in routine clinical practice in various European countries. Results from the primary analysis showed the real-world effectiveness and acceptable safety of Ave + Axi in a heterogeneous population. We report the final analysis. Methods: AVION (NCT04941768) was a prospective noninterventional study of patients with aRCC treated with 1L Ave + Axi in Germany, Greece, Belgium, or Russia. Patients were observed for 24 months. The primary objective was OS rate at 12 months. Secondary objectives included OS rate at 24 months; median OS and PFS; ORR; duration of response (DOR); safety; and health-related quality of life (HRQOL; NCCN/NFKSI-19). Results: By data cutoff (July 23, 2025), 104 patients were included. Median age was 70 years (range, 37-87), and 70.2% were male. International Metastatic RCC Database Consortium risk group was favorable, intermediate, poor, or not reported 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. Median duration of Ave or Axi treatment was 9.8 and 8.8 months, respectively. Median OS was not reached (95% CI, not estimable [NE]-NE), and 12- and 24-month OS rates (95% CI) were 81.8% (72.6%-88.1%) and 69.2% (58.4%-77.8%), respectively. Median PFS was 11.1 months (95% CI, 6.9-18.1), and 12- and 24-month PFS rates (95% CI) were 47.3% (36.6%-57.2%) and 31.1% (20.2%-42.6%), respectively. In patients evaluable for response (n = 91), ORR was 48.4% (95% CI, 37.7-59.1), and disease control rate was 80.2% (95% CI, 70.6-87.8); median DOR was not reached (95% CI, NE; range, 0-23.9 months). Treatment-related adverse events (TRAEs) of any grade occurred in 68.3% and were grade ≥3 in 19.2% and serious in 13.5%. TRAEs led to permanent discontinuation of Ave or Axi in 3.8% or 10.6%, respectively, and led to death in 1 patient (immune-mediated myocarditis). The most common TRAEs of any grade were diarrhea (27.9%), fatigue (14.4%), hypertension (10.6%), dysphonia (8.7%), and nausea (8.6%); the most common grade ≥3 TRAE was diarrhea (4.8%). HRQOL scores were generally stable during treatment, including total score and subscales. Conclusions: The final analysis of AVION confirms the real-world effectiveness, acceptable safety, and favorable tolerability with maintained HRQOL of 1L Ave + Axi treatment in a heterogeneous real-world population with aRCC in Europe, consistent with earlier results and previous studies. Clinical trial information: NCT04941768 .

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