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BMS' Opdivo fails to win over NICE as adjuvant melanoma therapy

Published on 10/09/18 at 12:53pm

Bristol-Myers Squibb has failed to convince NICE to approve the use of its PD-1 inhibitor immunotherapy Opdivo (nivolumab) as an adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease.

The UK watchdog rejected the application for the drug to be made available on the NHS due to concerns over its clinical effectiveness for overall survival.

“There are no trials directly comparing adjuvant nivolumab with routine surveillance, which is usual current management for completely resected stage III and IV melanoma.

This means there is uncertainty about the clinical effectiveness of nivolumab compared with routine surveillance,” the institute said in its draft guidance. “Evidence from an ongoing trial shows improved recurrence-free survival with nivolumab compared with ipilimumab. However, the Effect on overall survival with nivolumab in this trial is uncertain because it is still ongoing.”

Because of this doubt over the robustness of the data, “cost-effectiveness estimates for nivolumab are uncertain”, the institute added. Not only does this make it impossible for the drug to be accessible on the NHS at its current price, but NICE also confirmed that Opdivo would also not be made available on the Cancer Drugs Fund (CDF).

 Opdivo has shown its superiority to BMS’ CTLA4 inhibitor Yervoy (ipilimumab) as an adjuvant therapy in melanoma through data revealed last July, reducing recurrence-free survival rates by 35%. There were nearly 16,000 new cases of melanoma in the UK in 2015. Five-year survival estimates for stage III disease stand at around 50-55% and 8-24% for stage IV disease.

Matt Fellows

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