Proven efficacy in patients with advanced CSCC who received LIBTAYO in Study 15401,5†

Response rates in patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation1

Objective Response Rate (ORR) and Duration of Response (DOR) with LIBTAYO
  • In the mCSCC, laCSCC, and combined advanced CSCC groups, median durations of follow-up were 16.5 months, 9.3 months, and 11.1 months, respectively. In the mCSCC LIBTAYO 350 mg Q3W group, median duration of follow-up was 8.0 months1
  • Median TTR was 1.9 months (range, 1.7-9.1 months) in the combined advanced CSCC groups and 2.1 months (range, 2.0-8.3 months) in the mCSCC LIBTAYO 350 mg Q3W group1,5

  • Data cutoff was September/October 2018.5
  • The numerator includes the number of patients whose observed DOR reached at least the specified times of 6 or 12 months. Patients who did not have the opportunity to reach the specified time point were included in the denominator only.1
  • Plus sign (+) denotes ongoing at last assessment.1
  • CR=complete response; CSCC=cutaneous squamous cell carcinoma; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; NE=not evaluable; NR=not reached; Q2W=every 2 weeks; Q3W=every 3 weeks; TTR=time to response.

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

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®).
  • ||For patients who have complicated cases of locally advanced disease in which curative surgery and curative radiation therapy are not feasible. Assessment feasibility of radiation therapy should be made by a radiation oncologist.
  • NCCN®=National Comprehensive Cancer Network® (NCCN®).

Please see full Prescribing Information.
This video reviews the clinical trial designs, efficacy results, and safety data of LIBTAYO in patients with advanced CSCC.
Chapter 1 Dr Cohen's introduction and background on CSCC
Chapter 2 Overview of LIBTAYO
Chapter 3 LIBTAYO clinical trial designs for Study 1423 and Study 1540
Chapter 4 Efficacy results of LIBTAYO in advanced CSCC (time to response, objective response rate, duration of response)
Chapter 5 Safety profile of LIBTAYO in locally advanced CSCC
Chapter 6 Important Safety Information
Chapter 7 References

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron PharmaceuticaIs, 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 March 24, 2021. 3. Rischin D, Khushalani NI, Schmults CD, et al. Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC): follow-up at 43 months. Poster presented at: European Association of Dermato Oncology Congress 2021 Virtual Scientific Meeting. 15-17 April 2021. 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 January 19, 2021. 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 July 28, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org.