LIBTAYO 350 mg (cémiplimab)

The Committee deems that the clinical benefit of LIBTAYO (cemiplimab) is SUBSTANTIAL in the subgroup of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).

Considering:

• the available data based on three cohorts from a phase 2 non-comparative study and on compassionate use programme (ATU) data having suggested an efficacy of cemiplimab in terms of objective response rate in a heterogeneous population with locally advanced or metastatic cutaneous carcinoma,
• the substantial medical need for patients in whom all the other treatment options have been exhausted (patients who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy),

 But taking into account:

• uncertainties with respect to the specific effect size of this medicinal product, considering the absence of robust comparative data,

The Transparency Committee considers that, as the dossier currently stands, LIBTAYO (cemiplimab) provides no clinical added value (CAV V) in the subgroup of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation and who are not eligible for chemotherapy (situation of failure or contraindication to chemotherapy).