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

Longer-term follow-up data for LIBTAYO1,2*

Group 1 data and Groups 2 and 3 data represent a 2-year and 1-year follow-up from the primary analysis, respectively2

Tumor response assessment, time to response and duration of response with LIBTAYO

In a prespecified analysis by ICR2:

  • ORR was 48.4% (95% CI, 39.5%-57.4%) among patients who had not received prior anticancer systemic therapy (n=128)
  • ORR was 41.5% (95% CI, 29.4%-54.4%) among patients who had received prior anticancer systemic therapy (n=65)
  • *For these longer-term data, the predetermined data cutoff date was October 2019.
  • Based on number of patients with confirmed CR or PR.2
  • 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.3
  • Adapted with permission from Rischin et al, 2020.2
  • 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

Longer-term follow-up data for Study 1540: Time to response2

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

Longer-term follow up clinical study 1540 time to response

§Based on number of patients with confirmed CR or PR.2

Median time to complete response for combined advanced CSCC group was 11.2 months (IQR, 7.4-14.8)

References: 1. Data on file. Regeneron Pharmaceuticals, Inc. 2. 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. 3. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron PharmaceuticaIs, Inc., and sanofi-aventis U.S. LLC.