The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) endorsing NHS use of an Opdivo (nivolumab) and Yervoy (ipilimumab) combination in renal cell carcinoma (RCC).
The news means around 1,700 people with kidney cancer in England will have a new treatment option, and signifies an important landmark in the treatment landscape, representing the first approval of an immuno-oncology combination therapy for first-line patients with this type of cancer in England.
American drug-maker Bristol-Myers Squibb announced that the immunotherapy combination is to be immediately available via the Cancer Drugs Fund, based on data from a Phase III head-to-head study, which was stopped early due to an overall survival efficacy benefit versus sunitinib, a current standard of care.
The Phase III CheckMate 214 study consisted of 1096 patients, and found a 37% decreased risk of death in intermediate and poor-prognostic risk patients, as well as an objective response rate of 42% and complete response rate of 9%.
“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.
In Europe, Opdivo is already licensed as monotherapy for various different cancers, including adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, those with advanced renal cell carcinoma (RCC) after prior therapy and relapsed or refractory classical Hodgkin’s Lymphoma (cHL) after autologous stem cell transplantation and treatment with brentuximab vedotin.
RCC is currently the seventh most common cancer and rates have risen by a worrying 47% over the last decade or so in the UK.