Avelumab plus axitinib combintion approved for untreated advanced kidney cancer in Scotland

The Sottish Medicine Consortium (SMC) have issued a final decision to recommend the avelumab plus axitinib combination for untreated advanced kidney cancer for patients in Scotland.

We are delighted that as from today, kidney cancer patients in Scotland can get NHS funding for avelumab in combination with axitinib for the first-line treatment of patients with advanced or metastatic renal cell carcinoma (RCC).

Avelumab is an immunotherapy which acts by boosting the immune system to attack the kidney cancer. Axitinib is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), which interferes with the growth of blood vessels that supply the tumour to enable it to grow. The combination has been shown to extend the time period before the tumour starts to grow again (progression-free survival) compared with standard treatment with sunitinib. However, overall survival data remain immature.

The combination was approved for untreated advanced RCC by the European Medicines Agency in May 2019 and is available in the USA and Canada. The combination was also designated a breakthrough therapy and was available to patients under the Early Access to Medicines Scheme (EAMS) in the UK.

The JAVELIN Renal 101 clinical trial demonstrated that the combination significantly lowered the risk of disease progression or death by 31% and nearly doubled response rates (52.5%) compared with sunitinib (27.3%) in patients with advanced RCC, regardless of whether the patients were PD-L1 positive or negative or they had low, intermediate or high risk RCC.

Progression-free survival was nearly doubled with an average of 13.8 months in the combination group and 7.0 months in the sunitinib group.

KCSN was consulted for the SMC health technology appraisal of avelumab plus axitinib, and have been heavily involved in the submission of a proposal to support this drug combination. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting, in which KCSN represented the patient voice.

Dr Balaji Venugopal from the Beatson West of Scotland Cancer Centre, said; “Advanced renal cancer is a lethal disease that significantly affects patients’ quality of life and causes mortality. The combination of avelumab and axitinib that has been proven to be effective in all risk groups is a step change in the management of advanced renal cancer and also provides options for clinicians and patients in treating this lethal disease.”

Rose Woodward, Founder of KCSN and a patient herself, said; “I am so pleased on behalf of kidney cancer patients and their families in Scotland to see this approval from the Scottish Medicines Consortium for this innovative immunotherapy + TKI combination treatment. Kidney cancer patients deserve the best possible care and treatment and in Scotland clinicians now have access to the widest range of life extending drugs to treat this difficult disease.”

Scottish patient, Alice Clelland, said; “I was diagnosed with secondary kidney cancer and, due to the location of the cancer, no treatment options were available to me. I joined a clinical trial of avelumab + axitinib. As a result of this treatment I have enjoyed three years of good health with minimal side effects. In the past three years I have seen my granddaughter start school, my daughter get married and the birth of my grandson; I am a very lucky lady. I am delighted to hear that after today’s announcement, patients in Scotland will now be able to get access to this treatment on the NHS in Scotland.”

If you have any questions about this news, please get in touch with Rose or Karen at the KCSN.

See the avelumab/axitinib public information summary on the SMC website here

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