NICE recommends BMS’ Opdivo-Yervoy combination for RCC

Bristol-Myers Squibb (BMS) has announced that the National Institute of Health and Care Excellence (NICE) has recommends Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy to treat National Health Service (NHS) patients in England with renal cell carcinoma (RCC).

RCC is the most common type of kidney cancer and the seventh most common of all cancers. The approval of Opdivo plus Yervoy represents the first approval of immuno-oncology combination therapy for first-line patients with this type of cancer.

BMS UK and Ireland general manager Lynelle Hoch said: "We are delighted that NICE has recognised the combination of nivolumab plus ipilimumab as an important treatment option for many patients with advanced RCC. Importantly, the decision may allow intermediate- and poor risk patients in England to receive immunotherapy as a first-line option for the first time.

"Today’s recommendation helps to further our goal of ensuring that increasing numbers of patients will be able to benefit from potentially life-extending medicines."

Kidney Cancer Support Network co-founder Rose Woodward said: "Today’s decision is of importance to advanced kidney cancer patients, who may now have access to more treatment options.

"Kidney cancer is a devastating disease and at the most advanced stage prognosis is poor. Having access to this combination therapy on the NHS is therefore an important new addition and a vital step in our fight to extend survival."

NICE’s recommendation is based on data from the Phase III CheckMate 214 study in which the combination therapy showed superior overall survival compared to standard of care sunitinib; There was a 37% lower risk of death in intermediate and poor prognostic risk patients in the Opdivo-Yervoy group.

Other co-primary endpoints were objective response rate and progression free survival. Objective response rate was 42% in the drug group, compared to 27% in sunitinib arm, and PFS was 11.6 months versus 8.4 months.

As a result of this recommendation, Opdivo plus Yervoy will be available immediately to NHS patients in England through the Cancer Drug Fund.

Opdivo is a programme cell death-1 (PD-1) immune checkpoint inhibitor that harnesses the body’s immune system to restore an anti-tumour response.

It has been approved in the European Union as a monotherapy for a range of oncology indications, but only for melanoma and RCC as a combination therapy with Yervoy.

The drug is available as a monotherapy on the NHS for melanoma, RCC, non-small cell lung cancer, urothelial carcinoma, squamous cell cancer of the head and neck and classical Hodgkin lymphoma.

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