The National Institute for Health and Care Excellence (NICE) has released a draft guidance rejecting MSD’s Keytruda (pembrolizumab) when used in combo with Pfizer’s Inlyta (axitinib) to treat advanced renal cell carcinoma (RCC).

NICE already routinely commissions various drugs for first-line treatment of RCC, including Aveo’s Fotivda (tivozanib), Pfizer’s Sutent (sunitinib) and an Opdivo (nivolumab) Yervoy (ipilimumab) combination - the latter being through the Cancer Drugs Fund.

The organisation says that despite evidence suggesting that the Keytruda combo would be welcomed by patients, there was uncertainty around the long-term benefit. The organisation also cited inadequate clinical and cost-effectiveness as reasons for not recommending the drugs.

NICE reminds that Keytruda is given intravenously every three weeks and Inlyta is taken orally twice a day, with list prices of £2,630 per vial (100 mg) and £3,517 for 56 tablets (5 mg), respectively.

In September last year The European Commission (EC) approved the combination for the indication, based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that the drug reduced the risk of death by 47% compared with Sutent in the indication.

The combination also demonstrated an improvement in progression-free survival (PFS) and objective response rate (ORR) compared with the Pfizer drug.

The decision came after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the combo in July.

Approximately 12,900 people are diagnosed with kidney cancer each year in the UK, with the most common type being RCC, which accounts for 80% of kidney cancer cases and 3% of all cancer cases in the UK.