In patients with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation

Long-term follow-up data for LIBTAYO1,3,5†

The following data represent a 3-year follow-up for Group 1, and 2-year follow-up for Group 2 and Group 3. Follow-ups for each group are based on time from primary analysis for Study 1540

Tumor response assessment, time to response and duration of response with LIBTAYO
  • For these long-term data, the predetermined data cutoff date was October 11, 2020.3
  • Based on number of patients with confirmed CR or PR.3
  • §Percentages are based on number of patients with confirmed CR or PR. The numerator includes the number of patients whose observed duration of response reached at least the specified time. Patients who did not have the opportunity to reach the specified timepoint were included in the denominator only. Because responses for some patients are ongoing, the percentages at the specified timepoints may increase as data mature.5
  • Adapted with permission from Rischin et al, 2021.3
  • CI=confidence interval; CR=complete response; CSCC=cutaneous squamous cell carcinoma; ICR=independent central review; IQR=interquartile range; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; NE=not evaluable; NR=not reached; ORR=objective response rate; PR=partial response; Q2W=every 2 weeks; Q3W=every 3 weeks.

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

Long-term follow-up data for Study 1540: Time to response5II

Median time to response for the combined advanced CSCC group was 2.1 months (range, 1.9-3.7)

Longer-term follow up clinical study 1540 time to response


Median time to complete response for combined advanced CSCC group was 11.3 months (range, 1.8-22.8)
  • IIFor these long-term data, the predetermined data cutoff date was October 11, 2020.5
  • Based on number of patients with confirmed CR or PR.5

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 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.