LIBTAYO was validated in the largest prospective clinical trial program for advanced CSCC1,5-13

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.15

  • *Data cutoff date was June 30, 2018. Median duration of follow-up was 13.3 months.1,16
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.