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NICE says no to nivolumab with ipilimumab for renal cell carcinoma

NICE has taken the decision not to recommend nivolumab with ipilimumab for untreated metastatic renal cell carcinoma (RCC).

In new draft guidance, NICE acknowledges that clinical trial evidence has shown that nivolumab with ipilimumab is substantially more effective than sunitinib for untreated advanced intermediate- or poor-risk RCC. However, it concludes that it is uncertain if this survival benefit would be maintained in the long-term.

The main evidence for nivolumab with ipilimumab came from the CheckMate 214 trial. In an interim analysis of the trial data in August 2017, nivolumab with ipilimumab was found to significantly improve progression-free survival (PFS) and overall survival (OS) in patients with intermediate- or poor-risk RCC compared with sunitinib. Median PFS was 11.0 months (95% CI 8.3-15.2) for nivolumab with ipilimumab and 8.3 months (95% CI 7.0-9.8) for sunitinib (HR 0.76; 99.1% CI 0.60-0.95).

Median overall survival was not reached (95% CI 28.2-not evaluable) for nivolumab with ipilimumab and 26.0 months (95% CI 22.1-not evaluable) for sunitinib (HR 0.63; 99.8% CI 0.44-0.89).

Based on the strength of the survival benefit shown, CheckMate 214 was stopped early. The NICE appraisal committee concluded that the results are uncertain as the data are immature, with a median follow-up of 25.2 months.

Nivolumab with ipilimumab will not be available under NICE’s end-of-life criteria.

The draft guidance is now open for consultation. Closing date for receipt of comments is 12 January 2019.


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