Cabozantinib with nivolumab is recommended as an option for untreated advanced renal cell carcinoma in adults, only if:
their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and
nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and
the companies provide cabozantinib and nivolumab according to their commercial arrangements.
This recommendation is not intended to affect treatment with cabozantinib with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Untreated advanced renal cell carcinoma is treated based on risk status (favourable, intermediate and poor risk). For all risk statuses, treatment includes sunitinib, pazopanib or tivozanib. For intermediate- and poor-risk cancer, people may also be offered cabozantinib alone, nivolumab plus ipilimumab, or lenvatinib plus pembrolizumab.
Clinical trial evidence suggests that people having cabozantinib plus nivolumab live longer and have longer before their cancer gets worse than people having sunitinib. How well it works compared with sunitinib may change depending on the cancer's risk status, but this evidence is uncertain.
There are no clinical trials directly comparing cabozantinib plus nivolumab with treatments other than sunitinib. An indirect comparison suggests that people who have cabozantinib plus nivolumab have more time before their cancer gets worse than pazopanib or tivozanib. It also suggests that cabozantinib plus nivolumab works as well as nivolumab plus ipilimumab and lenvatinib plus pembrolizumab. But these results are uncertain because of the evidence and methods used in the indirect comparison.
For favourable-risk cancer, the cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources. For intermediate- and poor-risk cancer, the cost-effectiveness estimates are uncertain. But, the most likely estimates for cabozantinib plus nivolumab compared with lenvatinib plus pembrolizumab and nivolumab plus ipilimumab are within the range that NICE normally considers an acceptable use of NHS resources. So, cabozantinib plus nivolumab is recommended for people with intermediate- and poor-risk cancer if nivolumab plus ipilimumab or lenvatinib plus pembrolizumab would have otherwise been offered.