Effective October 1, 2019
Libtayo J-code available
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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

Engage his antitumor immune response to improve his outlook1

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.