On August 28, 2020 Merck & Co. reported that Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) has been turned down by NICE as first-line treatment for patients with advanced renal cell carcinoma (RCC) (Press release, Merck & Co, AUG 28, 2020, View Source [SID1234564138]).
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The anti-PD-1 therapy combo was approved in Europe in September 2019 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 sunitinib in the indication.
However, NICE says while "short-term clinical trial evidence" shows that the combination is more effective than sunitinib for people with untreated renal cell carcinoma, "it is uncertain if there is a long-term benefit," which means that "cost-effectiveness estimates are uncertain".
Kidney cancer UK has slammed the decision.
"The decision by NICE concerning axitinib and pembrolizumab is extremely disappointing for the kidney cancer community," said the charity’s health professional nurse Susanna Smith.
"This is a combination which showed great results in the clinical trial and has been very well tolerated by people. The combination has been used widely in the US to great success since its approval…so unfortunately this decision will be leave us lagging behind in proving affective, cutting edge treatment options for patients in England and Wales."
"Axitinib and pembrolizumab improves survival significantly and has an important role to play in the treatment of kidney cancer. Rejecting the most active cancer treatments is disappointing for patients," added Professor Thomas Powles, consultant medical oncologist at St Bartholomew’s Hospital, London.