20: A UK real-world observational study of avelumab + axitinib (A+Ax) in advanced renal cell carcinoma (RCC): exploratory analysis of 24-month interim results in patients with non-clear cell histology
Medical Manager Immuno-Oncology RCC Pfizer Oncology
Background: A+Ax therapy is approved and funded for patients with advanced RCC in the UK. However, real-world data on patients with advanced non-clear cell RCC (nccRCC) are scarce. This exploratory analysis reports real-world outcomes of patients with advanced nccRCC receiving A+Ax in the UK.
Methods: Of 78 patients with advanced RCC, 15 patients with nccRCC from 6 UK sites were included in this analysis. Inclusion criteria included aRCC diagnosis, age ≥18 years, and A+Ax initiation on or after August 2019 via Early Access to Medicines Scheme. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and best response up to 24 months were the outcomes of interest. Data were analysed descriptively.
Results: Median baseline age was 65.2 years (range, 43.1-84.1 years); all patients were male, 10 were white, and ethnicity was not recorded for 4. All patients had an Eastern Cooperative Oncology Group performance status 0-1. International Metastatic RCC Database Consortium risk status was favourable in 3 patients, intermediate in 8, and poor in 4. Tumour histology was unclassified in 8 patients, papillary in 3, and chromophobe in 2. At 12 months, OS was 60% (95% CI, 40%-91%), and PFS was 27% (95% CI, 12%-62%). At 24 months, OS was 47% (95% CI, 27%-80%; n=14), PFS was 20% (95% CI, 7%-55%; n=14), and ORR was 31% (95% CI, 6%-56%; n=15). Best responses within 24 months were: complete/partial response in 5 patients, stable disease in 6, and progressive disease in 2.
Conclusions: This exploratory UK real-world study provides novel insights into the effectiveness of A+Ax in a small subset of patients with nccRCC and suggests that A+Ax demonstrates activity in these patients. Further research is warranted.