ASCO GU 2022: Avelumab Plus Axitinib in Advanced Renal Cell Carcinoma: 12-Month Interim Results From a Real-World Observational Study in the United Kingdom

( The Poster Session C on the third day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022, Poster Session C focused on Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers. In this session, Dr. Nathan presented results of a real world observational trial assessing outcomes of avelumab and axitinib among patients with advanced renal cell carcinoma (aRCC) in the United Kingdom.

The combination of avelumab and axitinib was found to have has demonstrated superior progression-free survival (PFS) and objective response rate (ORR) benefit across all International Metastatic RCC Database Consortium (IMDC) risk groups compared to sunitinib in patients with previously untreated aRCC in the JAVELIN Renal 101 trial. As result, it received approval and funding in many countries, including the United Kingdom. In this study, the authors report 12-month real-world outcomes of avelumab and axitinib in patients with aRCC in the UK.

Adult patients (age 18 years and older) who were treated with avelumab and axitinib for aRCC outside the context of a clinical trial beginning August 1, 2019 via an early access to medicines scheme were recruited at 4 UK sites. Informed consent was obtained for all included patients. Patient informed consent was obtained. Primary endpoints of interest include overall survival (OS), best response, PFS and ORR at 12 months. Descriptive statistics are provided. Recruitment continued until January 2022 and follow-up will continue until July 2023.

To date, this analysis includes 36 patients with a minimum 12 month follow up. Median age at baseline was 66.2 (range, 39.8-84.1) years. In terms of IMDC risk status, 39% of patients had favorable-risk disease, 42% had intermediate-risk disease, and 17% had poor-risk disease while, and 3% were unknown. 89% of patients had an ECOG PS of 0 or 1.

The median time between aRCC diagnosis and initiation of avelumab and axitinib was 1.8 months (range 0.03 to 28.8 months). Most patients had clear cell (72%) or other (25%) histology, had undergone nephrectomy (61%), and had 1 or 2 sites of metastatic disease (69%). The most common metastatic sites were lung (50%), bone (36%), and lymph node (25%).

The 12-month OS rate was 86% (95% CI 74.8-97.4) and 53% (95% CI 36.5-69.1of patients were progression-free at 12 months.


The objective response rate ORR was 53% (95% CI 36.5-69.1) with 6% achieving a complete response and 47% achieving partial response.

At the time of the first and second infusions, 39% of patients received axitinib at the starting dose of 5 mg twice daily, 47% had a dose escalation, and 14% had a dose reduction. Infusion-related reactions (IRRs) were observed in 9 patients (25%) in the first 12 months, with 10 events total. All 10 IRRs required the use of high-dose corticosteroids.

Thus, the authors conclude that this real-world study of avelumab and axitinib demonstrates comparable clinical responses to previously published data.

Presented by: Paul D. Nathan, MD, PhD, Mount Vernon Cancer Centre, Northwood, United Kingdom


Written by: Christopher J.D. Wallis, University of Toronto Twitter: @WallisCJD during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022

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