The National Institute for Health and Care Excellence (NICE) has approved avelumab with axitinib within England's Cancer Drugs Fund for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Clinical evidence for the treatment comes from the phase 3 JAVELIN Renal 101 trial of avelumab plus axitinib (442 patients) compared with sunitinib (444 patients) in advanced RCC.
Interim analysis of JAVELIN Renal 101 showed improved progression-free survival (PFS) with avelumab plus axitinib over sunitinib (hazard ratio [HR] 0.69; 95% CI 0.56-0.84) but the data on overall survival are immature. Uncertainty about overall survival (OS) created uncertainty about cost-effectiveness.
NICE noted that most patients in JAVELIN Renal 101 had clear-cell disease, but in NHS practice some have non-clear-cell disease. Clinical experts advised that there is no evidence that the results in people with cancers characterised by clear-cell histology would be generalisable to people with non-clear-cell disease. Therefore, there might be an argument to limit avelumab plus axitinib to people with clear-cell disease only, according to NICE.
Recommending the treatment for use within the Cancer Drugs Fund will allow long-term data to be collected and collated by histology to monitor whether there is a difference in effectiveness.
This article originally appeared on Univadis, part of the Medscape Professional Network.
