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Cabozantinib with nivolumab for untreated advanced renal cell carcinoma

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1 Recommendations

1.1

Cabozantinib plus nivolumab is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults.

1.2

This recommendation is not intended to affect treatment with cabozantinib plus 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 pembrolizumab plus lenvatinib.

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 the evidence of this is uncertain.

There are no clinical trials directly comparing cabozantinib plus nivolumab with other usual treatments. An indirect comparison suggests that people who have cabozantinib plus nivolumab have more time before their cancer gets worse than sunitinib, pazopanib or tivozanib. It also suggests that cabozantinib plus nivolumab works as well as nivolumab plus ipilimumab and pembrolizumab plus lenvatinib. But these results are uncertain because of the evidence and methods used in the indirect comparison.

Because of limitations with the clinical evidence, the cost-effectiveness estimates are uncertain. For favourable-risk cancer, the cost-effectiveness estimates are above what NICE normally considers a cost-effective use of NHS resources. For intermediate- and poor-risk cancer it was not possible to determine a reliable estimate. More analysis and validation is needed for the comparisons of cabozantinib plus nivolumab with pembrolizumab plus lenvatinib and nivolumab plus ipilimumab. So, cabozantinib with nivolumab is not recommended.