In patients with laBCC previously treated with an HHI,

LIBTAYO was validated in the largest prospective clinical trial for a PD-1 inhibitor

Chart, study 1620 trial design

Primary endpoint1

  • Confirmed objective response rate (ORR)
    assessed by independent central review (ICR)

Secondary endpoints included2

  • Duration of response
  • Complete response rate
  • Safety and tolerability

Study 1620 was an open-label, multicenter, phase 2, nonrandomized study that included 132 patients, of whom 84 had locally advanced BCC (laBCC) that had progressed on HHI therapy, were intolerant of prior HHI therapy, had not had an objective respose after 9 months on HHI therapy, or were intolerant of prior HHI therapy. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1,2

Study 1620 excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1 therapy or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or Eastern Cooperative Oncology Group Performance Status ≥2.1

  • BCC=basal cell carcinoma; HHI=hedgehog inhibitor; laBCC=locally advanced BCC; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; 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. Data on file. Regeneron Pharmaceuticals, Inc.