NICE has issued draft guidance which recommends cemiplimab within the Cancer Drugs Fund for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The draft guidance recommends that treatment with cemiplimab should be continued until disease progression or for up to 24 months.
Data on response and survival outcomes with cemiplimab come from two ongoing single-arm phase 1 (n=26) and phase 2 (n=167) trials. The overall response rate reported for the phase 1 trial was 50% (95% CI 29.9-70.1) and the results for the phase 2 trial were similar. Median progression-free survival results in the phase 2 trial at the most recent analysis were favourable. Median overall survival had not been reached in either trial.
NICE concluded that cemiplimab trial data are promising but uncertain. It said cemiplimab is likely to be considerably more effective than chemotherapy, and adverse events appear to be similar to other immunotherapies.
However, because of the uncertainty around cost-effectiveness and long-term survival benefit, and the lack of comparator data, the treatment cannot be recommended for routine use in the NHS. The draft guidance approves the treatment for use within the Cancer Drugs Fund while additional evidence is being gathered.
The draft guidance is now open for appeal and a final decision is expected early next month.