LIBTAYO was validated in the largest prospective clinical trial program for advanced CSCC1-10

Study 1423 was an open-label, multicenter, nonrandomized, multicohort study that included 26 patients with mCSCC (n=16) or laCSCC (n=10) who were not candidates for curative surgery or curative radiation. Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 48 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1

Study 1423 excluded patients with autoimmune disease who required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1–blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or ECOG PS ≥2.1

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

Efficacy endpoints in patients with advanced CSCC in Study 14231*:

  • ORR was 50% (13 out of 26 patients [95% CI, 30%-70%]); all responses were PRs
  • Median time to response was 1.9 months (range, 1.7-7.3 months)
  • 85% of responders (11 out of 13) reached a DOR ≥6 months

In this trial, DOR range was 1.0 to 20.3 months.12

*Data cutoff date was June 30, 2018. Median duration of follow-up was 13.3 months.1,12
Groups 1 and 2, of clinical study 1540 patients with mCSCC or laCSCC given LIBTAYO 3 mg/kg Q2W for up to 96 weeks. In Group 3, patients with mCSCC given LIBTAYO 350 mg Q3W for up to 54 weeks.

Study 1540—EMPOWER-CSCC 1—was a global, pivotal, open-label, nonrandomized, multicohort study that included 193 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation (targeted enrollment). Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 96 weeks or LIBTAYO 350 mg every 3 weeks for up to 54 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1

Study 1540 excluded patients with autoimmune disease who required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1–blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or ECOG PS ≥2.1

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

CR=complete response; CSCC=cutaneous squamous cell carcinoma; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; ICR=independent central review; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC; ORR=objective response rate; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; PR=partial response; PS=performance status; Q2W=every 2 weeks; Q3W=every 3 weeks.

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2020. 3. Foote MC, McGrath M, Guminski A, et al. Phase II study of single-agent panitumumab in patients with incurable cutaneous squamous cell carcinoma. Ann Oncol. 2014;25(10):2047-2052. 4. William WN Jr, Feng L, Ferrarotto R, et al. Gefitinib for patients with incurable cutaneous squamous cell carcinoma: a single-arm phase II clinical trial. J Am Acad Dermatol. 2017;77(6):1110-1113.e2. 5. Heath CH, Deep NL, Carroll L, et al. Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013;85(5):1275-1281. 6. Jenni D, Karpova MB, Mühleisen B, et al. A prospective clinical trial to assess lapatinib effects on cutaneous squamous cell carcinoma and actinic keratosis. ESMO Open. 2016;1(1):e000003:1-7. 7. Lewis CM, Glisson BS, Feng L, et al. A phase II study of gefitinib for aggressive cutaneous squamous cell carcinoma of the head and neck. Clin Cancer Res. 2012;18(5):1435-1446. 8. Sadek H, Azli N, Wendling JL, et al. Treatment of advanced squamous cell carcinoma of the skin with cisplatin, 5-fluorouracil, and bleomycin. Cancer. 1990;66(8):1692-1696. 9. Shin DM, Glisson BS, Khuri FR, et al. Phase II and biologic study of interferon alfa, retinoic acid, and cisplatin in advanced squamous skin cancer. J Clin Oncol. 2002;20(2):364-370. 10. Maubec E, Petrow P, Scheer-Senyarich I, et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011;29(25):3419-3426. 11. Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018;379(4):341-351. Supplementary material available at: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1805131/suppl_file/nejmoa1805131_protocol.pdf. Accessed January 15, 2021. 12. Data on file. Regeneron Pharmaceuticals, Inc.