LIBTAYO (cemiplimab)

Key points

Favourable opinion for reimbursement in the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

Most cutaneous squamous cell carcinomas (cSCC) have a good prognosis since they can be easily treated by surgery or radiotherapy. However, in very rare cases, these lesions progress to locally advanced forms in which surgery or curative radiation therapy are no longer possible (lacSCC) and to forms with intra-lymphatic, lymph node then distant metastases (mcSCC).

Advanced-stage cutaneous squamous cell carcinoma not suitable for surgery or radiotherapy is treated with systemic chemotherapy, for which the outcomes are poor, or with targeted EGFR inhibitor therapies, used off-label, with variable outcomes depending on the drugs: a response rate of 16% under gefitinib with a median overall survival of 12.9 months; a response rate of 28% under cetuximab and a median overall survival of 8.1 months and a response rate of 31% under panitumumab and a median overall survival of 11 months.

Role of the medicinal product in the care pathway

On the basis of currently available data, which has a low level of evidence, the Committee deems that LIBTAYO (cemiplimab) is a first-line treatment opinion for cutaneous squamous cell carcinoma not suitable for surgery or radiotherapy. In the absence of a comparison with the available alternatives, its role in the care pathway remains to be specified.