NICE Approves Avelumab with Axitinib for Untreated Advanced Renal Cell Carcinoma

Dawn O'Shea

September 04, 2020

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.

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