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Merck bags NICE recommendation for renal cell carcinoma adjuvant treatment

Patients will now be able to access immunotherapy at an earlier stage in their treatment pathway


Merck & Co – known as MSD outside the US and Canada – has announced that Keytruda (pembrolizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) as an option for the adjuvant treatment of renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults.

The decision marks the first time patients with RCC are able to access immunotherapy at an earlier stage in their treatment pathway.

Nephrectomy – removal of part or all of the kidney – is the standard treatment for early-stage RCC. However, even for kidney cancers detected at an early stage and treated with surgery, cancer recurs in up to 30% of patients and a further 20-40% of RCC cases become metastatic.

The approval means that Keytruda can now be used in patients with RCC, as an adjuvant therapy that harnesses the body’s own immune system to detect and fight off any cancer cells following nephrectomy.

Nick Turkentine, chief executive officer of Kidney Cancer UK, said: “Each year over 13,300 people are diagnosed with the disease in the UK and more than 4,700 lose their life.

“The importance of early diagnosis cannot be overstated as kidney cancer is often found incidentally; over 40% of those receiving a diagnosis show no signs, the most common being blood in pee, ache in the side or flank and excessive fatigue.”

NICE’s decision is based on positive results from KEYNOTE-564, a multicentre, randomised, double-blind, placebo-controlled trial that enrolled 994 patients with clear cell RCC at increased risk of recurrence after nephrectomy who had not previously received systemic therapy.

An analysis of the study found that Keytruda increased disease-free survival at 24 months compared with placebo, the primary efficacy endpoint of the trial. Overall survival at 24 months was also higher with Keytruda compared with placebo, although this did not reach significance, the company noted.

Dr Tom Waddell, consultant in medical oncology, gastro-oesophageal and renal unit, The Christie NHS Foundation Trust, said: “Immunotherapy has already revolutionised the treatment of renal cancer in the advanced disease setting.

“Now, thanks to the positive results of the KEYNOTE-564 trial, we have access to [Keytruda] at a much earlier point in the treatment pathway. By administering treatment soon after surgery, we can now hope to support more patients by preventing the cancer from ever returning.”

Article by
Emily Kimber

22nd September 2022

From: Research, Regulatory



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