The European Commission has approved the nivolumab plus ipilimumab combination for first-line treatment of people with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This is the first approval of a combination of immunotherapy agents for untreated advance RCC in the European Union.

This approval offers advanced RCC patients in Europe a first-line treatment with a complete response in almost 10% of patients, and a significant survival advantage over current standard of care with sunitinib.

The European Commission approval was based on data from the phase III CheckMate-214 clinical trial, which was stopped early after an interim analysis showed a significant increase in overall survival and a 37% decreased risk of death in intermediate- and poor-risk RCC patients compared with sunitinib.  The combination also demonstrated a higher objective response rate of 41.6% versus 26.5% for sunitinib, and a complete response rate of 9.4% versus 1.2% for patients on sunitinib. The combination was also associated with fewer severe and life-threatening adverse events compared to sunitinib (65% versus 76%).

This is fantastic news, which allows access to this innovative and highly effective treatment to European RCC patients. The National Institute for Health and Care Excellence (NICE) will be appraising the nivolumab plus ipilimumab combination for use within NHS England next week. KCSN have made a submission to the NICE appraisal committee on behalf of kidney cancer patients: we will keep you informed of the outcome of this meeting.

Read the Bristol-Myers Squibb press release here