SMC ‘yes’ to first immunotherapy combination for skin cancer patients

Allows adult patients with advanced melanoma to receive first-line treatment with the potentially life-extending combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) on the NHS in Scotland.

The SMC’s decision was primarily supported by data from a Phase III study (Checkmate -067), which showed that patients treated with the combination therapy saw their cancer kept at bay for almost four times longer than those treated with ipilimumab alone (progression free survival was 11.5 months with the combination vs. 2.9 months with ipilimumab alone.

“We are delighted that skin cancer patients in Scotland will now be able to access this innovative combination of immunotherapies for the first time,” said Gill Nuttall, Melanoma UK. “Advanced melanoma is an aggressive disease and the prognosis is often poor. The availability of the nivolumab plus ipilimumab combination therapy on the NHS is therefore an important new addition in the fight to extend survival. We hope this new therapy will give many patients more valuable time with their families and loved ones.”

Safety assessments showed Grade 3-4 adverse events (AEs) occurred in 55% of patients treated with the combination vs. 27% and 16% of those treated with ipilimumab and nivolumab monotherapy, respectively. AEs were generally managed using established guidelines and the majority of grade 3/4 AEs resolved with the use of immune modulating medication at a median of 5 weeks. Patients with poor prognostic factors had a similar safety profile to the entire study population.

In addition to the positive recommendation for nivolumab in combination with ipilimumab for skin cancer patients, the SMC has also issued guidance which will deny Scottish NHS patients with previously treated advanced kidney cancer the option of treatment with nivolumab. The SMC submission for kidney cancer included data from a pivotal Phase III trial showing that patients who received nivolumab as a second-line treatment lived an average of 5.4 months longer than those treated with a current standard therapy (everolimus).

“We are very happy for Scottish melanoma patients and their families who will now have access to the nivolumab plus ipilimumab combination therapy for melanoma,” said Ben Hickey, General Manager, UK and Ireland, “Our aim is to ensure all eligible patients in the UK are able to receive treatment with our innovative medicines and we will continue to work with the SMC to find a way forward for kidney cancer patients in Scotland.”