LIBTAYO®, a programmed death receptor-1 (PD-1) inhibitor, is the first and only FDA-approved therapy indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation1

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Objective Response Rate with LIBTAYO: 47.2% ORR, 43.5% PR, and 3.7% CR

ORR: 51 of 108 patients (95% confidence interval, 37.5%, 57.1%).1,2

61% of responders (31 of 51) reached a duration of response (DoR) of ≥6 months1,2,a,c

Median DoR not reached (range: 1-15.2+ months)1-3,a,c

a At time of data cutoff; based on a combined analysis of Studies 1423 and 1540, which were single-arm, open-label, multicenter, nonrandomized, multicohort studies. Median duration of follow-up was 8.9 months.1 See additional study design details.

b Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1

c Group 2 patients (locally advanced CSCC; cemiplimab-rwlc 3 mg/kg every 2 weeks) who started treatment less than 9 months prior to the data cutoff date and all Group 3 patients (metastatic CSCC; cemiplimab-rwlc 350 mg every 3 weeks) from Study 1540 are excluded from the efficacy analysis set.2

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