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We are delighted to announce that the Scottish Medicines Consortium (SMC), which reviews newly licensed medicines in Scotland, has published advice recommending the routine use of nivolumab plus ipilimumab for intermediate-/poor-risk advanced renal cell carcinoma (RCC) by NHS Scotland.
The nivolumab (Opdivo) plus ipilimumab (Yervoy) combination was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, which is for medicines used at the end of life and for very rare conditions. Overall survival was significantly longer in the nivolumab plus ipilimumab group compared with sunitinib (Sutent) in a phase III study in treatment naïve patients with intermediate/poor-risk advanced RCC.
The availability of this new treatment option heralds an innovative change in the treatment of advanced RCC, being the first approval of a combination of immunotherapy drugs for the treatment of RCC patients in the first-line available in Scotland.
The SMC’s decision is based on data from the phase 3 CheckMate 214 study, which enrolled 1096 patients. This study was stopped early due to outstanding survival results versus sunitinib, the current standard of care in the first-line. In CheckMate 214 there was a 37% decreased risk of death in intermediate- and poor-risk patients, as well as an objective response rate of 42% and complete response rate of 9%.
“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 KCSN. “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.”
KCSN would like to thank all those patients who contributed to the ipilimumab/nivolumab appraisal by the SMC, especially Alison Fielding who attended the EMA appeal meeting to represent the views and opinions of the wider kidney cancer community and helped to reverse their decision to eventually grant marketing authorisation for this novel treatment – a BIG thank you!
We would also like to thank all the clinicians who fought so hard for access to this innovative new treatment, and who highlighted the value of the combination in improving survival for people with advanced kidney cancer – we are STRONGER TOGETHER!