LIBTAYO was validated in the largest prospective clinical development program for advanced cutaneous squamous cell carcinoma (CSCC)1-9

Study 1423 was an open-label, multicenter, nonrandomized, multicohort study that included a total of 26 patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1 See exclusion criteria and recommended dosage below.

Patients with either mCSCC or laCSCC were given LIBTAYO 3 mg/kg Q2W for up to 48 weeks with a tumor response assessment every 8 weeks.

laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks.

Primary endpoint10

  • To characterize safety and tolerability of LIBTAYO

Secondary endpoints included10:

  • Antitumor activity


Study 1540—EMPOWER-CSCC 1—was a global, pivotal, open-label, nonrandomized, multicohort study that included a total of 137 patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation.1,11,12 Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1 See exclusion criteria and recommended dosage below.

In groups 1 and 2 patients with either mCSCC or laCSCC were given LIBTAYO 3 mg/kg Q2W for up to 96 weeks with a tumor response assessment every 8 weeks. In group 3 patients with mCSCC were given LIBTAYO 350 mg Q3W for up to 54 weeks with a tumor response assessment every 9 weeks.

laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks; Q3W, every 3 weeks.

Primary endpoint1,12

  • Confirmed objective response rate (ORR) by independent central review

Secondary endpoints included10-12:

  • Duration of response
  • Complete response rate


Studies 1423 and 1540 excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; a history of solid organ transplant; prior treatment with programmed death receptor-1/programmed death ligand 1 blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or Eastern Cooperative Oncology Group Performance Status ≥2.1

The recommended dose of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1

Efficacy results (N = 108) are presented as a combined analysis of 26 patients from Study 1423 and 82 patients from Study 1540.1

Safety analysis (N = 163) is presented as a combined analysis of 26 patients from Study 1423 and 137 patients from Study 1540.1,11
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Foote MC et al. Ann Oncol. 2014;25(10):2047-2052.
  3. William WN Jr et al. J Am Acad Dermatol. 2017;77(6):1110-1113, 1113.e1-1113.e2.
  4. Heath CH et al [published online for public access]. Int J Radiat Oncol Biol Phys. 2013;85(5):1275-1281. doi:10.1016/j.ijrobp.2012.09.030
  5. Jenni D et al. ESMO Open. 2016;1(1):e000003. doi:10.1136/esmoopen-2015-000003
  6. Lewis CM et al. Clin Cancer Res. 2012;18(5):1435-1446.
  7. Sadek H et al. Cancer. 1990;66(8):1692-1696.
  8. Shin DM et al. J Clin Oncol. 2002;20(2):364-370.
  9. Maubec E et al. J Clin Oncol. 2011;29(25):3419-3426.
  10. Migden MR et al. N Engl J Med. 2018;379(4):341-351.
  11. Data on file. Regeneron Pharmaceuticals Inc.
  12. Study of REGN2810 in patients with advanced cutaneous squamous cell carcinoma. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/study/NCT02760498. Published May 3, 2016. Updated January 14, 2019. Accessed April 8, 2019.