LIBTAYO® is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation1

LIBTAYO offers over 4 years of clinical treatment experience in patients with
advanced CSCC1-3*

*LIBTAYO was FDA approved in advanced CSCC in September 2018.1,4

Efficacy profile and results1,5

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Meaningful tumor reduction1,3,5

Review case studies of patients with advanced CSCC from clinical trials.

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For patients with mCSCC or laCSCC who received LIBTAYO 3 mg/kg Q2W in Study 1540 (n=137)1†:

LIBTAYO objective response rates
  • 79% of responders (50 out of 63) reached a DOR ≥6 months1,5‡
  • 54% of responders (34 out of 63) reached a DOR ≥12 months1,5‡
  • Median TTR was 1.9 months (range, 1.7-9.1 months)1

In an additional cohort in Study 1540 of 56 patients with mCSCC who received LIBTAYO 350 mg Q3W1†:

  • ORR was 41% (23 out of 56 patients [95% CI, 28%-55%])1‡
  • 65% of responders (15 out of 23) reached a DOR ≥6 months1

In this trial, median DOR was not reached (range, 1.9-24.2+ months).1‡

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

  • Data cutoff was September/October 2018.5
  • Median duration of follow-up was 11.1 months and 8.0 months in patients who received LIBTAYO 3 mg/kg Q2W and LIBTAYO 350 mg Q3W in Study 1540, respectively.1
  • See additional study design details inside.1
  • §PR is defined as a decrease of ≥30% in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. PR of externally visible disease is defined as a decrease of ≥50% in the sum of products of perpendicular longest dimensions of target lesions, per WHO Criteria. Nontarget lesions could not have progressive disease and there could be no new lesions. Responses had to be maintained for at least 4 weeks.1,5
  • ||CR is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to show a CR and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have shown a reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; patients with laCSCC in Study 1540 required biopsy to confirm a CR.1,5
  • Plus sign (+) denotes ongoing at last assessment.1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)6

NCCN Guidelines® for Squamous Cell Skin Cancer V.1.2021 recommend cemiplimab-rwlc (LIBTAYO®) as a preferred systemic therapy option for appropriate patients with advanced CSCC

Category 2A preferred recommendation6

NCCN preferred Category 2A Option in Advanced CSCC

Category 2A preferred recommendation6

NCCN Guidelines® for Squamous Cell Skin Cancer NCCN Guidelines® for Squamous Cell Skin Cancer
  • Category 2A recommendation is based upon lower-level evidence; there is uniform NCCN® consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise specified.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.

  • NCCN is a registered trademark of the National Comprehensive Cancer Network® (NCCN®).

  • CSCC=cutaneous squamous cell carcinoma; DOR=duration of response; NCCN®=National Comprehensive Cancer Network®; ORR=objective response rate; Q2W=every 2 weeks; Q3W=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; TTR=time to response; WHO=World Health Organization.


References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Study of REGN2810 in patients with advanced cutaneous squamous cell carcinoma. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/study/NCT02760498. Updated January 26, 2021. Accessed April 20, 2021. 3. 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. 4. Drugs@FDA: FDA-approved drugs. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761097. Updated June 25, 2020. Accessed September 8, 2020. 5. Data on file. Regeneron Pharmaceuticals, Inc. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Squamous Cell Skin Cancer V.1.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 11, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org.