Ipsen’s Cabometyx (cabozantinib) and Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) have been recommended by the National Institute for Health and Care Excellence (NICE) as a combination treatment for advanced kidney cancer.
The agency has specifically recommended the combination as a first-line therapy for adults with untreated advanced renal cell carcinoma (RCC) whose disease is intermediate or poor risk and if Opdivo plus BMS’ Yervoy (ipilimumab) or Eisai’s Lenvima (lenvatinib) plus Merck & Co’s Keytruda (pembrolizumab) would otherwise be offered.
RCC is the seventh most common cancer in the UK, with approximately 13,322 new cases of the disease diagnosed every year.
Until now, eligible RCC patients have only been able to access the Cabometyx/Opdivo combination in Scotland and Northern Ireland, where it has been approved since 2021.
NICE’s advice could benefit an estimated 2,287 people with advanced RCC across England and Wales annually.
Syed Ali, medical affairs director at Ipsen UK and Ireland, said: “We’re delighted that NICE has recommended [Cabometyx] in combination with [Opdivo] in this indication, ensuring equal access for patients throughout the UK.
“For people living with advanced kidney cancer and the healthcare teams supporting them, greater access to a variety of treatment options like this can provide much-needed comfort and hope.”
The decision was supported by positive results from a late-stage study, which demonstrated a 34% reduction in the risk of death for patients treated with the Cabometyx/Opdivo combination compared to Pfizer’s Sutent (sunitinib).
Four-year extended follow-up data also demonstrated a sustained and clinically meaningful overall survival for the Cabometyx/Opdivo combination versus Sutent, and median progression-free survival remained almost double that for the combination versus Sutent.
“The availability of [Cabometyx] in combination with [Opdivo] represents a step-change in the management of advanced kidney cancer and a valuable addition to the treatment options available,” said Dr John McGrane, consultant oncologist at Royal Cornwall Hospitals NHS Trust.
“Access to this treatment combination could provide valuable additional time for people living with advanced RCC in England and Wales,” McGrane added.
Cabometyx, originally developed by Exelixis, has been exclusively licensed to Ipsen outside the US and Japan, where it is marketed by Exelixis and Takeda, respectively.