New draft guidance from NICE does not recommend pembrolizumab with axitinib for untreated advanced renal cell carcinoma (RCC).
Short-term clinical trial evidence shows that pembrolizumab with axitinib is more effective than sunitinib for people with untreated RCC, but it is uncertain if there is a long-term benefit. As a result, the cost-effectiveness estimates of the treatment are uncertain.
NICE has also said that pembrolizumab with axitinib is not suitable for use in the Cancer Drugs Fund because it is unlikely to be cost-effective at its current price, even if the uncertainty about its effectiveness is reduced.
Also, NICE said, pembrolizumab with axitinib does not meet NICE’s criteria to be a life-extending treatment at the end of life.
The clinical evidence for pembrolizumab with axitinib for untreated advanced RCC came from KEYNOTE-426, an open-label, randomised phase 3 trial that compared pembrolizumab plus axitinib with sunitinib (median follow up of 12.8 months). The primary outcome measures were overall survival (hazard ratio [HR] 0.53; 95% CI 0.38-0.74; P=0.00005) and progression-free survival (HR 0.69; 95% CI 0.57-0.84; P=0.00014).
Median survival was not reached in either arm. There was no evidence presented to NICE comparing pembrolizumab plus axitinib with tivozanib or pazopanib. Tivozanib and pazopanib were assumed to have equal efficacy and safety to sunitinib.
The appeal period for this appraisal closes at 5 pm on Friday 11 September 2020.
