Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

“When used alone, ipilimumab and nivolumab are both potentially life extending medicines, each blocking different processes that cancers use to evade our immune system,” said Dr James Larkin, Consultant Oncologist at The Royal Marsden, London. “Using these two medicines together in a double-hit approach provides complementary action, allowing us to target the cancer more effectively. The result is a new option that can offer longer control of melanoma than ipilimumab alone. This decision by NICE is very welcome news.”

The decision from NICE was supported by data from a pivotal Phase III clinical study (Checkmate -067), in which some patients treated with the combination therapy saw their cancer kept at bay for almost four times longer than those treated with ipilimumab alone, regardless of BRAF gene mutational status (progression free survival was 11.5 months with the combination vs. 2.9 months with ipilimumab alone). 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 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.

“Once melanoma reaches an advanced stage, it is an aggressive and life-threatening disease which is difficult to treat because it has spread to other parts of the body. Today’s decision is hugely significant for patients because it means that they will be able to receive a treatment option that could extend their lives,” said Gill Nuttall, CEO and Founder of Melanoma UK. “Providing rapid access to new medicines is an essential component in the fight to improve cancer survival rates in the UK, which still lag behind many countries in Europe.”

The effects of the combination therapy have been further demonstrated by the results of a recently presented Phase II study, which showed that 61% of patients with BRAF wild-type tumours treated with the combination therapy demonstrated an objective response rate, with over one in five patients achieving a complete response. The combination therapy also demonstrated a 2-year overall survival rate of 69% compared to 53% for ipilimumab alone in patients with BRAF wild-type advanced melanoma.

“Combining ipilimumab and nivolumab is a game-changing approach to the treatment of patients with advanced melanoma because using both medicines together can provide an even more powerful attack on cancer cells than we have previously seen with either medicine alone and I am delighted that NHS patients will be some of the first in Europe to have access to this latest treatment approach, said Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland. “Our clinical trial programme continues to investigate the potential of this combination for treating other cancers and we hope that more patients will be able to benefit from this innovation in the future.”