The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending nivolumab with ipilimumab for use within Cancer Drugs Fund.
Bristol-Myers Squibb Pharmaceuticals Limited said that the combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) has been recommended to treat NHS patients in England with an advanced form of the most common type of kidney cancer, renal cell carcinoma (RCC).
They say that this recommendation signifies an important landmark in the treatment landscape, representing the first approval of an Immuno-Oncology (I-O) combination therapy for first-line patients with this type of cancer in England. I-O works by stimulating the body’s immune system to recognise and eliminate cancer cells.
Nivolumab and ipilimumab will be immediately available on the Cancer Drugs Fund (CDF) as a first-line treatment option for previously-untreated intermediate- and poor-prognostic risk advanced RCC, and could be a treatment option for up to 1,700 patients each year in England.
RCC is currently the seventh most common cancer and rates have risen by 47% over the last decade or so in the UK, which is faster than most other common cancers, including lung and bowel cancer. In 2015, more than 12,500 people were diagnosed with kidney cancer in the UK and around 4,500 people die from the disease each year – an average of 12 people every day.
In England specifically, around one in four cases of kidney cancer (25%-31%) are diagnosed when the patient is already at an advanced stage. Of those patients diagnosed at the most advanced stage, stage IV, approximately only 5% will survive their cancer for five years or more.
The recommendation is based on data from the Phase III CheckMate 214 study of 1,096 patients, which was stopped early after a planned interim analysis showed that the combination of nivolumab and ipilimumab demonstrated superior overall survival compared to sunitinib, a current standard of care.
The decision from NICE will mean the combination will be available immediately to NHS patients in England via the Cancer Drugs Fund.
“Today’s decision is of importance to advanced kidney cancer patients, who may now have access to more treatment options,” said Rose Woodward, Co-founder of the Kidney Cancer Support Network. “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.”
“It’s very good news that the combination of nivolumab and ipilimumab has now been approved for use in patients with intermediate- and poor risk advanced renal cell carcinoma. A study has demonstrated that this immunotherapy combination is superior to sunitinib in extending overall survival and may now benefit patients whose lives are threatened by a cancer that has increased in incidence by nearly 50% in the last decade,” said Dr Paul Nathan, Consultant Medical Oncologist at Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust.
“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,” said Lynelle Hoch, General Manager, Bristol-Myers Squibb UK & Ireland.