Avelumab with axitinib for untreated advanced renal cell carcinoma (MA review of TA645) [ID6294]

Renal cell carcinoma (RCC) is a cancer that usually originates in the lining of the tubules of the kidney (the smallest tubes inside the nephrons) that help filter the blood and make urine. RCC is the most common type of kidney cancer accounting for more than 80% of cases.(1) There are several types of RCC.

The main ones are clear cell (accounting for around 75% of cases) papillary and chromophobe.(1)RCC is categorised into stages 1 to 4. Stage 1 and 2 includes tumours which are localised to the kidney. Stage 3 denotes disease that is locally advanced and/or has spread to regional lymph nodes.

Metastatic RCC in which the tumour has spreadbeyond the regional lymph nodes to other parts of the body is defined as stage 4.

Treatment for RCC is also dependent on risk status as defined by the International Metastatic RCC Database Consortium (IMDC).In 2021 10193 new kidney cancer cases were diagnosed in England.(2) Around 39% to 45% were stage 3 or 4 at diagnosis.(3) The 5-year survival is around 75% and 15% for stage 3 and stage 4 disease respectively.(4)Current treatment options for untreated advanced RCC include vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs) PD-1 or PD-L1 immune checkpoint inhibitors and CTLA-4 inhibitors.

TKIs offered for untreated RCC include sunitinib pazopanib or tivozanib as recommended by NICE technology appraisal guidance (TA169 TA215 and TA512).

In addition TA645 recommends avelumab with axitinib (a PD-1/PD-L1 inhibitor with a TKI) for untreated advanced RCC for use within the Cancer Drugs Fund (CDF) while further data is collected.

This recommendation is the subject of this evaluation.For people with intermediate or poor-risk cancer TA542 recommends cabozantinib (a TKI) and TA780 recommends nivolumab plus ipilimumab (a PD-1 inhibitor with a CTLA-4 inhibitor).

TA858 recommends lenvatinib with pembrolizumab (a TKI with a PD-1/PD-L1 inhibitor) as an option where nivolumab with ipilimumab would otherwise be offered.

TA964 recommends cabozantinib with nivolumab (a TKI with a PD-1 inhibitor) as an option where nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered.References1. Cancer Research UK. Kidney cancer types and grades. Accessed September 2024.2. NHS England Digital. Cancer Registrations Statistics England 2021 – first release counts only counts of cancer diagnoses tables.

Accessed September 2024.3. NHS England Digital. Cancer Registrations Statistics England 2021 – first release counts only cancer incidence by stage. Accessed September 2024.4. Cancer Research UK. Survival for kidney cancer. Accessed September 2024