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NICE recommends Merck/Pfizer’s PD-L1 inhibitor Bavencio for kidney cancer

Picks up approval as a first-line treatment for advanced cancer


The UK’s National Institute for Health and Care Excellence (NICE) has recommended Merck KGaA and Pfizer’s immunotherapy Bavencio as a treatment for kidney cancer for use within the Cancer Drugs Fund.

Bavencio (avelumab), in combination with Pfizer’s tyrosine kinase inhibitor Inlyta (axitinib), has been recommended as a first-line treatment for adult patients with advanced renal cell carcinoma (RCC) – the most common type of kidney cancer.

The recommendation was based on the results from the JAVELIN Renal 101 study, in which Bavencio in combination with Inlyta met the primary endpoint of improved progression-free survival in patients with PD-L1-positive clear cell advanced RCC.

Compared to treatment with targeted kinase inhibitor sunitinib, the Bavencio combination treatment improved median PFS by 5.3 months versus eight months in the overall population.

Regardless of PD-L1 status, in the overall population the combination also lowered the risk of disease progression or death by 31%.

Merck KGaA and Pfizer first scored regulatory approval for Bavencio in this setting back in May 2019, when it won US Food and Drug Administration (FDA) approval as a first-line treatment for advanced RCC.

The combination of checkpoint inhibitors, like Bavencio, with targeted kinase inhibition via drugs such as Inylta has become a new standard in first-line advanced RCC, a patient group which historically had poor survival chances.

Approximately 20%-30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated at an earlier stage will go on to develop metastases.

“We are delighted with the decision to make this treatment available to UK patients. The combination has the potential to improve the lives of patients living with RCC as well as help healthcare professionals optimise their patients’ treatment,” said Olivia Ashman, oncology medical director at Pfizer UK.

“NICE’s positive recommendation also addresses the significant need for first-line treatments with a benefit across all prognostic risk groups,” she added.

Bavencio is also approved for the rare skin cancer Merkel cell carcinoma and in second-line bladder cancer – although it is competing head-to-head in the latter indication with a number of cancer immunotherapies including Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).

Article by
Lucy Parsons

31st July 2020



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