Bristol Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the combination of nivolumab plus ipilimumab for adult patients with previously untreated advanced renal cell carcinoma (RCC) that is intermediate- or poor-risk.

The decision is supported by five-year data from the Checkmate-214 trial, which showed improved overall survival (OS) and overall response rates (ORR) compared to sunitinib.

The NICE decision means the combination will continue to be a treatment option for patients diagnosed with intermediate- or poor-risk advanced RCC in England. “A diagnosis of kidney cancer is devastating for the patient and their loved ones, regardless of the stage in which it is diagnosed.

However, for patients diagnosed at the latest stage, the chances of a full recovery are low,” said Nick Turkentine, Chief Executive of Kidney Cancer UK.

“Survival rates for kidney cancer in the UK are amongst the lowest in Europe and we are delighted that patients will continue to be able to access this treatment in their fight against this potentially deadly disease.”

Kidney cancer is the seventh most common cancer in the UK, accounting for 4% of all new cancer cases.

RCC is the most common type of kidney cancer, accounting for more than 80% of cases.

Around 13,300 new cases (2016-2018) and 4,600 deaths (2016-2018) from kidney cancer are recorded in the UK each year.

Kidney cancer relative survival rates in England are among the lowest in Europe, with 47% of men and 48% of women expected to survive for five years, compared to 60% and 62% respectively in Europe.

Typically, only around 12% of the 1,700 people in England diagnosed with kidney cancer at its latest stage (stage 4) survive for more than five years.

“I am very pleased that I will continue to be able to offer my patients nivolumab plus ipilimumab following their diagnosis of advanced renal cell carcinoma,” said Dr Richard Griffiths, Consultant in Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust. “The combination has become an important option since being made available on the Cancer Drugs Fund in 2019.

I welcome the NICE decision to continue to provide access to this treatment for people threatened by this aggressive cancer.”

The NICE recommendation is based on five-year data from the Checkmate-214 study, which showed that OS, ORR and progression-free survival (PFS) were higher in previously untreated intermediate- and poor risk patients treated with the combination of nivolumab plus ipilimumab (n=425) compared to those treated with sunitinib (n=422).

In the intermediate- and poor-risk group:

• 43% of those treated with the combination were still alive at five years compared to 31% of those treated with sunitinib [HR (95% CI) 0.68 (0.58–0.81); P < 0.0001]

• The ORR in patients treated with the combination was 42% (37–47) versus 27% (23–31) for those treated with sunitinib (95% CI)

• The five-year PFS probability for patients treated with the combination was 31% compared to 11% in those treated with sunitinib [(HR (95% CI) 0.73 (0.61–0.87); P = 0.0004]; at the primary analysis in 2018, PFS did not reach statistical significance

• Comparable rates of treatment-related adverse events of any grade occurred in patients in the intent-to-treat group treated with the combination (n=547) compared to those treated with sunitinib (n=535) (94% vs 98%), while fewer grade 3-4 treatment-related adverse events were reported in the combination group verses sunitinib (48% vs 64%).

“We are grateful that patients got access to this treatment through the CDF while efficacy and safety data from the Checkmate-214 study matured,” said Dr Hubert Bland, Executive Medical Director UK and Ireland, Bristol Myers Squibb “This NICE decision offers patients continued access to a range of treatments, including immunotherapy combinations, which can potentially improve the outlook for patients with advanced renal cell carcinoma.”

Source: Bristol Myers Squibb