Real-world Outcomes of Avelumab Plus Axitinib in Advanced RCC

A 24-month analysis highlighted overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and best response to avelumab-plus-axitinib treatment in patients with advanced renal cell carcinoma (aRCC).

Results were presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Combination therapy with avelumab plus axitinib in previously untreated aRCC has demonstrated superior PFS and ORR compared with sunitinib across all International mRCC Database Consortium (IMDC) risk groups.

Anand Sharma, MD, DPhil, MRCP, MBBS, and colleagues reported on 24-month real-world outcomes in patients with aRCC receiving this combination regimen in the United Kingdom. Patients were recruited from 9 sites, and inclusion criteria were diagnosis of aRCC, initiation of avelumab plus axitinib on or after August 1, 2019, and age of at least 18 years.

Total recruitment was 130 patients, though the presented analysis included 78 patients with a minimum follow-up of 24 months. Follow-up will continue until July 2023.

Researchers noted that median time between aRCC diagnosis and therapy initiation was 2.5 months (range, 0.03-90.4 months; n=77). IMDC risk status was favorable in 42% (n=33) of patients, intermediate in 41% (n=32), and poor in 17% (n=13). Clear cell histology was the most prevalent (81%). Sixty-eight percent (n=53) of patients had undergone nephrectomy, and 74% (n=58) had 1 or 2 metastatic sites at the index date.

OS rate at 24 months was 60%, and OS rates by IMDC risk status were: favorable, 76% (95% CI, 61.1%-90.4%); intermediate, 63% (95% CI, 45.7%-79.3%); and poor, 15% (95% CI, 0%-35.0%).

PFS rate at 24 months was 31%, and median PFS was 9.1 months.

ORR (n=76) at 24 months was 59%, with 4% (n=3) achieving complete response and 55% (n=42) achieving partial response.

Best responses observed within 24 months were complete response in 4% (n=3), partial response in 54% (n=42), stable disease in 29% (n=23), and progressive disease in 10% (n=8). Median duration of response was 11.9 months.

Researchers concluded that these real-world outcomes were in line with findings from prior clinical trials, with no new emerging adverse events.