Candidates for LIBTAYO

Metastatic CSCC1
  • Nodal metastasis
  • Distant metastasis
Locally advanced CSCC1
  • Locally advanced CSCC patients who were not candidates for curative surgery or curative radiation
Factors to consider when determining candidacy for surgery and radiation2,a



  • CSCC that has recurred in the same location after 2 or more surgical procedures and curative resection is deemed unlikely

Location of disease

  • CSCC in anatomically challenging locations for which surgery may result in severe disfigurement or dysfunction (eg, removal of all or part of a facial structure, such as nose, ear, or eye; or requirement for limb amputation)

Invasive disease

  • CSCC with significant local invasion that precludes complete resection


  • Other conditions deemed to be contraindicating for surgery


Location of disease

  • CSCC in anatomically challenging locations for which radiation therapy (RT) would be associated with unacceptable toxicity risk in the context of the patient's overall medical condition

Prior treatment

  • Patient has previously received RT for CSCC, such that further RT would exceed the threshold of acceptable cumulative dose


  • Clinical judgment that tumor is unlikely to respond to RT
  • Other conditions deemed to be contraindicating for RT

a Physician assessment may vary.

Baseline characteristics1

Characteristics of patients with CSCC enrolled in Studies 1423 and 1540

Advanced CSCC
(N = 108)
Metastatic CSCC, n 75
Metastatic patients with distant metastasis, % 69
Metastatic patients with only nodal metastasis, % 31
Locally advanced CSCC, n 33
Median age, years (range) 71 (38-96)
Male, % 85
White, % 97
Any prior radiotherapy, % 79
Prior cancer-related surgery, % 96
Received at least 1 prior anticancer systemic therapy, % 50
ECOG Performance Status, %
0 43
1 57

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

  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Migden MR et al. N Engl J Med. 2018;379(4):341-351.