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NICE turns down Keytruda/Inlyta combo for kidney cancer

Cost-effectiveness agency says the long-term benefit is uncertain


NICE has said that the recently-approved combination of Merck & Co/MSD’s Keytruda with Pfizer’s Inlyta shouldn’t be funded by the NHS for use as first-line therapy for kidney cancer.

In preliminary draft guidance issued this morning, the UK’s medicines cost-effectiveness agency accepts that clinical trials show the combination is better than Pfizer’s older drug Sutent (sunitinib) in previously untreated renal cell carcinoma (RCC) – the most common form of kidney cancer.

However, the long-term benefit of checkpoint inhibitor Keytruda (pembrolizumab) and tyrosine kinase inhibitor Inlyta (axitinib) in these patients is uncertain, which makes it hard to estimate its cost-effectiveness, according to NICE.

The agency also says it can’t recommend the regimen for coverage by the Cancer Drugs Fund – which covers the cost of cancer drugs until confirmatory data is available – because “uncertainties in the clinical evidence would not be resolved through data collection”.

The Keytruda/Inlyta combination was approved by the EMA for first-line RCC last September, but according to NICE it “does not meet…criteria to be a life-extending treatment at the end of life”.

The EU approval was based on the phase 3 KEYNOTE-426 trial, which demonstrated that the Keytruda plus Inlyta reduced the risk of death by 47% compared with Sutent.

The results outperformed MSD’s main rival in the checkpoint inhibitor category – Bristol-Myers Squibb – which had built a useful position in first-line RCC with its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) thanks to the Checkmate-214 study.

Opdivo/Yervoy reduced the risk of death by 37% in that trial, leading some analysts to speculate that Keytruda – already dominant in lung cancer – could also squeeze out BMS’ drugs in kidney cancer.

Keytruda has an additional advantage, having been approved for RCC across all International Metastatic RCC Database Consortium (IMDC) risk categories, while Opdivo is only approved for patients with intermediate- and poor-risk RCC.

Keytruda/Inlyta is however also competing in Europe with the combination of Pfizer/Merck KGaA’s Bavencio (avelumab) with Inlyta, which was approved by the EMA last October and will benefit from Pfizer promoting both its own products.

The unquestioned winner among these combinations is Inlyta of course. Pfizer reported sales of the drug rose 249% to $295m in the US last year, mainly as a result of its approval with checkpoint inhibitors for first-line RCC. Total 2019 sales for the drug were $477m, up more than 60%.

Article by
Phil Taylor

12th February 2020

From: Regulatory



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