LIBTAYO (cémiplimab) - CBCla ou CBCm

Key points

Approval of the reimbursement of LIBTAYO (cemiplimab) monotherapy for the treatment of adult patients with locally advanced or metastatic basocellular carcinoma (laBCC or mBCC), whose condition has progressed or who are exhibiting Hedgehog pathway inhibitor (HPI) intolerance. 

No therapeutic improvement, based on the data available.

Role in therapeutic strategy?

The first-line treatment of these advanced forms of basocellular carcinoma (BCC) is based on the use of Sonic Hedgehog pathway inhibitors, Vismodegib or Sonidegib. Indeed, most cases of BCC express mutations of this pathway, making them accessible to this type of targeted therapy.  The oral medicinal products, Vismodegib and Sonidegib, make it possible to obtain high objective response rates. For Vismodegib, the objective response rates are in the region of 43% in locally advanced BCC (laBCC), and 30% in metastatic BCC (mBCC). For Sonidegib, the objective response rates are 56% in laBCC, and 8% in mBCC. These Sonic Hedgehog pathway inhibitors are frequently associated with side-effects that may limit their use, particularly in older patients: weight loss, anorexia and ageusia, vomiting, fatigue, etc.

In cases of failure to respond to these treatments or of intolerance making it impossible to continue treatment, no appropriate treatment was hitherto available. Chemotherapy is very ineffective on this type of tumour and also poorly tolerated in the older cohort.

Role of the medicinal product:

LIBTAYO (cemiplimab) is a second-line treatment indicated for adult patients with locally advanced or metastatic basocellular carcinoma, that has progressed or is exhibiting Hedgehog pathway inhibitor (HPI) intolerance.