LIBTAYO achieved rapid, substantial, and durable responses1,2

For patients with mCSCC or laCSCC receiving 3 mg/kg every 2 weeks in Study 1540:

Median time to tumor response was 1.9 months.
Time to response1

Median time to response was rapid (1.9 months; range 1.7 to 9.1 months), based on an open-label, single-arm trial that did not include comparisons to other treatments (first assessment was performed at 8 weeks)

47.2% of patients received an objective response.
Objective response rate1,2,*

46% ORR (63 out of 137 patients;
95% CI: 37%, 55%)

31% PR (42 out of 137 patients)†;
15% CR (21 out of 137 patients [95% CI: 9%, 22%])‡

61% of responders reached a DoR of greater than or equal to 6 months.
Duration of response

79% of responders (50 out of 63 patients) reached
a DOR of ≥6 months1,2,*

54% of responders (34 out of 63 patients) reached
a DOR of ≥12 months1,2,*

Median DoR was not reached
(range: 1.9–24.2+ months)1-3

  • * Median duration of follow-up was 11.1 months for combined CSCC in Study 1540.1 See additional study design details.
  • † Partial response is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. Partial response of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest diameters 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.2
  • ‡ Complete response is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to be a complete response, and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; laCSCC patients in Study 1540 required biopsy to confirm CR. 1,2
  • "+" denotes ongoing at last assessment.1

In an additional cohort in Study 1540, 56 mCSCC patients received LIBTAYO at a dose of 350 mg intravenously every 3 weeks for up to 54 weeks. With a median duration of follow-up of 8.0 months, the confirmed ORR was 41% (95% CI: 28, 55), and 65% of responders had a DOR ≥6 months.1

Among 26 CSCC patients in Study 1423, 16 had mCSCC and 10 had laCSCC. One patient in the mCSCC group was dosed at 1 mg/kg every 2 weeks. The rest received 3 mg/kg every 2 weeks. With a median duration of follow-up of 13.3 months, the confirmed ORR was 50% (95% CI: 30, 70); all responses were PRs. The median time to response was 1.9 months (range: 1.7–7.3 months), and 85% of responders had a DOR ≥6 months.1

  • CI, confidence interval; CR, complete response; CSCC, cutaneous squamous cell carcinoma; DoR, duration of response; laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; ORR, objective response rate; PR, partial response; Q2W, every 2 weeks; Q3W, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; WHO, World Health Organization.

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

Patient profiles
  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.