The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the combination of nivolumab plus ipilimumab to treat NHS patients in England with an advanced form of the most common type of kidney cancer - renal cell carcinoma (RCC).

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.

The therapy 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.

This could be a treatment option for up to 1,700 patients each year in England.

“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.”

RCC is currently the seventh most common cancer and rates have risen by 47 percent 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 percent - 31 percent) 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 percent will survive their cancer for five years or more.

“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 percent in the last decade,” said Dr Paul Nathan, Consultant Medical Oncologist at Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust.

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 co-primary outcome measures were overall survival, objective response rate and progression-free survival in IMDC immediate- and poor- prognostic risk patients:

• The combination of nivolumab (3mg/kg) plus low-dose ipilimumab (1mg/kg) demonstrated a significant improvement in overall survival, with a 37 percent decreased risk of death in intermediate- and poor-prognostic risk patients (n=425), compared to a current standard of care, sunitinib (n=422) (HR 0.63; 99.8% CI: 0.44 to 0.89; p<0.001). The overall survival benefit was observed regardless of PD-L1 expression level. The median overall survival was not yet reached at the point of analysis (95% CI: 28.2 to not estimable [NE]), compared to 25.9 months for patients treated with sunitinib (HR 0.63; p<0.001).
• The objective response rate was 42 percent (95% CI: 37 to 47) in the nivolumab plus ipilimumab arm, versus 27 percent (95% CI: 22 to 31) in the sunitinib arm (p<0.001). The complete response rate was 9 percent in the nivolumab plus ipilimumab arm, versus 1% in the sunitinib arm.
• The median progression-free survival was 11.6 months (95% CI: 8.7 to 15.5) and 8.4 months (95% CI: 7.0 to 10.8) respectively (HR 0.82; 99.1% CI: 0.64 to 1.05; p=0.03; not significant per the prespecified 0.009 threshold).
• The combination therapy was associated with numerically fewer overall Grade 3 or 4 treatment-related adverse events compared to sunitinib (46% [n=250] versus 63% [n=335] respectively). The most common adverse events were fatigue, pruritus, diarrhoea and rash.

The decision from NICE will mean the combination will be available immediately to NHS patients in England via the CDF.

“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. “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.”

Source: Bristol-Myers Squibb