The National Institute for Health and Care Excellence has published draft guidelines rejecting NHS funds for Opdivo/Yervoy for untreated metastatic renal cell carcinoma.

Explaining the decision, the Institute said that while clinical trial evidence shows that the Opdivo (nivolumab)/Yervoy (ipilimumab) combination “is substantially more effective” than Pfizer’s sunitinib for people with untreated advanced intermediate- or poor-risk renal cell carcinoma, whether the survival benefit would be maintained in the long-term is “uncertain”.

Cost-effectiveness estimates for the therapy are higher than what NICE normally considers acceptable, despite a commercial arrangement designed to reduce the its cost to the NHS.

The combination was approved in the US earlier this year for first-line use in kidney cancer patients on the back of data from the Phase III CheckMate-214 clinical trial, which showed “a significant and unprecedented increase in overall survival (OS) in this patient population compared to a current standard of care, sunitinib,” according to BMS.

The therapy was shown to cut the risk of death by 37 percent versus sunitinib, while the objective response rates were 41.6 percent and 26.5 percent, respectively.

Also, an OS benefit was observed regardless of PD-L1 expression level, but there was no significant difference seen in progression free survival between the two treatment arms.

Currently, only 36 percent of patients with advanced RCC survive beyond one year, and only 8 percent will live past five years, highlighting the need for new treatment options.

European approval for Opdivo/Yervoy in the first-line renal cell carcinoma setting is pending, following a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use last month.