Clinical studies1

Study designs

Study 1423 was an open-label, multicenter, nonrandomized, multicohort study that included a total of 26 patients with advanced CSCC.* 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.

Study 1423 trial design

CSCC, cutaneous squamous cell carcinoma; laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks.

Study 1540 was an open-label, multicenter, nonrandomized, multicohort study that included 82 patients with advanced CSCC.* Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 96 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.

Study 1540 trial design

Major efficacy outcome measures

  • Confirmed objective response rate (ORR) by independent central review (ICR)
  • Duration of response by ICR
  • * Both studies excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; a history of solid organ transplant; prior treatment with anti–PD-1/anti–PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or Eastern Cooperative Oncology Group Performance Status ≥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.

CSCC, cutaneous squamous cell carcinoma; laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; PD-1, programmed death receptor-1; PD-L1, programmed death ligand 1; Q2W, every 2 weeks.

Efficacy results are presented as a combined analysis of patients with advanced CSCC (metastatic or locally advanced disease): 26 from Study 1423 and 82 from Study 1540.

Safety data reflect exposure to LIBTAYO in 163 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1423 and Study 1540.
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.