Efficacy1

Efficacy results are presented as a combined analysis of 26 patients with advanced CSCC from Study 1423 and 82 patients from Study 1540. Of these 108 patients, 75 had metastatic CSCC and 33 had locally advanced CSCC. The efficacy analysis was conducted when all patients had the opportunity for at least 6 months of follow-up.

Efficacy results—metastatic CSCC, locally advanced CSCC, and combined CSCC

Efficacy endpointsa Metastatic
CSCC
(n = 75)
Locally advanced
CSCC
(n = 33)
Combined
CSCC
(N = 108)
Confirmed objective response rate
Objective response rate, %
(95% CI, %)
46.7
(35.1, 58.6)
48.5
(30.8, 66.5)
47.2
(37.5, 57.1)
Complete response (CR) rate,b % 5.3 0 3.7
Partial response (PR) rate, % 41.3 48.5 43.5
Duration of response (DOR)
Range in months 2.8-15.2+ 1-12.9+ 1-15.2+
Patients with DOR ≥6 months, n (%) 21 (60) 10 (63) 31 (61)
  • aMedian duration of follow-up: metastatic CSCC: 8.1 months; locally advanced CSCC: 10.2 months; combined CSCC: 8.9 months.
  • bOnly includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response.
  • “+” denotes ongoing at last assessment.
  • CI, confidence interval; CSCC, cutaneous squamous cell carcinoma.

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 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.

  • The major efficacy outcome measures were confirmed objective response rate (ORR), as assessed by independent central review (ICR), and ICR-assessed duration of response.
  • * 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.
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.