NICE has recommended cemiplimab for use within the Cancer Drugs Fund for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended that treatment with cemiplimab should be continued until disease progression or for up to 24 months (whichever is sooner).
Clinical data on response and survival outcomes for cemiplimab were reported in two single-arm trials. All 26 patients in the phase 1 trial, and 123 of the 167 patients in the phase 2 trial, had a weight-based dose of 3 mg/kg of cemiplimab every two weeks. Data for people who had the anticipated licensed fixed-dose regimen of 350 mg every three weeks are limited to 44 patients in the third group of the phase 2 trial, all of whom had metastatic disease.
The overall response rate reported in the original company submission 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 also appear favourable. Median overall survival has not been reached in either trial, which suggests a promising treatment benefit.
NICE concluded that cemiplimab trial data are promising but uncertain and, therefore, it is not known for certain whether the end-of-life criteria apply. The cost-effectiveness estimates for the treatment are currently above the normal NICE threshold, so cemiplimab cannot be recommended for routine use in the NHS.
However, NICE considered that if more mature data become available from ongoing trials, this could confirm the expectation that the end-of-life criteria apply. “If this is the case, there is plausible potential for cemiplimab to be a cost-effective treatment. Therefore, cemiplimab is recommended for use within the Cancer Drugs Fund,” NICE has decided.