Effective October 1, 2019
Libtayo J-code available
J9119
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LIBTAYO®, a programmed death receptor-1 (PD-1) inhibitor, is the first and only FDA-approved therapy indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation1

Engage his antitumor immune response to improve his outlook1

Objective Response Rate with LIBTAYO: 47.2% ORR, 43.5% PR, and 3.7% CR

ORR: 51 of 108 patients (95% confidence interval, 37.5%, 57.1%).1,2

61% of responders (31 of 51) reached a duration of response (DoR) of ≥6 months1,2,a,c

Median DoR not reached (range: 1-15.2+ months)1-3,a,c

a At time of data cutoff; based on a combined analysis of Studies 1423 and 1540, which were single-arm, open-label, multicenter, nonrandomized, multicohort studies. Median duration of follow-up was 8.9 months. 1 See additional study design details.

b Complete response is defined as disappearance of all target lesions for at least 4 weeks. 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; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1,2

c Group 2 patients (locally advanced CSCC; cemiplimab-rwlc 3 mg/kg every 2 weeks) who started treatment less than 9 months prior to the data cutoff date and all Group 3 patients (metastatic CSCC; cemiplimab-rwlc 350 mg every 3 weeks) from Study 1540 are excluded from the efficacy analysis set.2

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 Feasible4

NCCN Guidelines® recommend cemiplimab-rwlc (LIBTAYO), an immune checkpoint inhibitor, as the only preferred systemic therapy option for appropriate patients with4:

  • 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 user, 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. Migden MR et al. N Engl J Med. 2018;379(4):341-351.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Squamous Cell Skin Cancer V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed November 10, 2019. To view the most recent and complete version of the guidelines, go online to NCCN.org.