Approved as a first- or later-line therapy for a broad range of patients with advanced cutaneous squamous cell carcinoma (CSCC)1

Characteristics of patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation in Study 1540

Advanced CSCC
(N = 193)
Metastatic CSCC, n 115
Locally advanced CSCC, n 78
Median age, years (range) 72 (38 - 96)
Male, % 83
White, % 97
ECOG Performance Status, %
   0 45
   1 55

CSCC, cutaneous squamous cell carcinoma;
ECOG, Eastern Cooperative Oncology Group.


Additional characteristics of enrolled patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation in Study 15401,2

66% of patients received LIBTAYO as first-line systemic therapy.

66%
of patients received LIBTAYO as first-line systemic therapy

90% of patients had received prior cancer-related surgery.

90%
of patients had received prior cancer-related surgery

68% of patients had received any prior radiotherapy.

68%
of patients had received any prior radiotherapy

77% of metastatic patients had distant metastasis.

77%
of metastatic patients had distant metastasis

23% of metastatic patients had only nodal metastasis.

23%
of metastatic patients had only nodal metastasis

Programmed death ligand-1 (PD-L1) testing is not required before starting LIBTAYO.

LIBTAYO is approved for a wide variety of patients with advanced CSCC1

Candidates for LIBTAYO

Metastatic CSCC1
  • Nodal metastasis
  • Distant metastasis
Locally advanced CSCC1
  • Locally advanced CSCC patients who are not candidates for curative surgery or curative radiation
Situations when surgery or radiation may not be appropriate3-5a

Surgery:

Invasive disease

  • Locally invasive: tumor extending into underlying tissue, cartilage, bone, or nerve
  • Nodal involvement due to direct invasion from overlying skin
  • Perineural involvement due to direct extension that is apparent on imaging
  • In-transit metastasis of the skin (without evidence of nodal, parotid, or distant disease)

Location of disease

  • Periorbital lesions threatening the eye
  • Nasal or auricular lesion requiring rhinectomy or auriculectomy
  • CSCC lesions of head and neck area with direct extension into sinuses

 

Expected deformity or morbidity

  • Anticipation of substantial morbidity or deformity from surgery

Recurrence

  • Recurrence of CSCC at the same site after 2 or more surgical procedures
  • Deep recurrence underlying site of previously resected cutaneous lesion (if no nodal or metastatic involvement)

Other

  • Patient refusal of surgery
  • Other conditions deemed to be contraindicating for surgery

Radiation:

Location of disease

  • Anatomically challenging locations for which radiation therapy (RT) would be associated with unacceptable toxicity

Prior treatment

  • Further RT would exceed the threshold of acceptable cumulative dose

Other

  • Patient refusal of RT
  • Clinical judgment that tumor would be unlikely to respond to RT
  • Other conditions deemed to be contraindicating for RT
  • aAssessment by individual physician may vary.
Response rates
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Rischin D, Khushalani NI, Schmults CD, et al. Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC): longer follow-up. Poster presented at: American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program; May 29-31, 2020.
  3. Data on file. Regeneron Pharmaceuticals Inc.
  4. Alam M et al. J Am Acad Dermatol. 2018;78(3):560-578.
  5. Migden MR et al. N Engl J Med. 2018;379(4):341-351.