Effective October 1, 2019
Libtayo J-code available
J9119
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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 radiation.1

Engage his antitumor immune response to improve his outlook1


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

Objective Response Rate with LIBTAYO: 47.2% ORR, 95% confidence interval, 37.5% to 57.1%, 43.5% PR, and 3.7% CR

The median duration of response was not reached1

79% of responders (50 out of 63) reached a duration of response (DoR) of ≥6 months1,2

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

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

Among 26 CSCC patients in Study 1423, 16 had mCSCC and 10 had laCSCC. With a median duration of follow-up of 13.3 months, confirmed ORR was 50% (95% CI: 30%, 70%). All responses were PR, and 85% of responders had a DOR ≥6 months.1

In these trials, responses lasted between 1 month and more than 2 years (24.2+ months); plus sign (+) denotes ongoing at last assessment.1,2

a Median duration of follow-up was 11.1 months for combined CSCC in Study 1540.1 See additional study design details.

b 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

c 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

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 preferred Category 2A Option for Advanced CSCC
NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)

Category 2A* (Preferred) Recommended Systemic Therapy Option for Patients With Advanced Cutaneous Squamous Cell Carcinoma If Curative Surgery and Curative Radiation Therapy Are Not Feasible3

NCCN Guidelines® recommend cemiplimab-rwlc (LIBTAYO), an immune checkpoint inhibitor, as a preferred systemic therapy option for appropriate patients with3:

  • Locally advanced or regional CSCC when curative surgery and curative radiation therapy are not feasible
  • Distant metastatic or regionally recurrent CSCC when curative surgery and curative radiation therapy are not feasible
*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.

  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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Squamous Cell Skin Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. To view the most recent and complete version of the guidelines, go online to NCCN.org.