NOW APPROVED
LOCALLY ADVANCED BCC

LIBTAYO is the FIRST AND ONLY treatment indicated for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.1

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clinical data of LIBTAYO
in locally advanced BCC

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In a study of patients with laBCC previously treated with an HHI,

LIBTAYO demonstrated clinically meaningful response rates1

LIBTAYO objective response rates
No PD-L1 or TMB testing is required before starting
LIBTAYO for laBCC1,2
Median duration of follow-up was 15.1 months for
patients with laBCC1

LIBTAYO demonstrated durable responses1


LIBTAYO observed duration of response
Median DOR was not reached for laBCC
(range: 2.1-21.4+ months)1
Median time to response was 4.2 months
(range: 2.1-13.4)1
  • Plus sign (+) denotes ongoing at last assessment.1

Adverse reactions in ≥10% of patients receiving LIBTAYO in Study 16201*

Adverse reactions in patients receiving LIBTAYO in Study 1620

  • *Of the 132 patients in the safety analysis of Study 1620, 84 patients had laBCC.1
  • Serious ARs occurred in 32% of patients. Serious ARs that occurred in >1.5% (at least 2 patients) were urinary tract infection, colitis, acute kidney injury, adrenal insufficiency, anemia, infected neoplasm, and somnolence1
  • Fatal adverse reactions occurred in 1.5% of patients who received LIBTAYO, including acute kidney injury and cachexia1
  • Permanent discontinuation of LIBTAYO due to an AR occurred in 13% of patients1
  • ARs resulting in permanent discontinuation of LIBTAYO in >1.5% (at least 2 patients) were colitis and general physical health deterioration1
  • Dosage delays of LIBTAYO due to an AR occurred in 34% of patients. ARs which required dosage delay in >2% of patients (at least 3 patients) included blood creatinine increased, diarrhea, colitis, fatigue, headache, pneumonitis, and urinary tract infection1
  • The most common ARs reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash, pruritus, and upper respiratory tract infection1
  • The most common Grade 3 or 4 ARs (>2%) were hypertension, colitis, fatigue, urinary tract infection, pneumonia, increased blood pressure, hypokalemia and visual impairment1
  • The most common (>3%) laboratory abnormality worsening from baseline to Grade 3 or 4 was hyponatremia1
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.1
  • Fatigue is a composite term that includes fatigue, asthenia, and malaise.1
  • Musculoskeletal pain is a composite term that includes arthralgia, back pain, myalgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal stiffness, musculoskeletal chest pain, musculoskeletal discomfort, and spinal pain.1
  • §Rash is a composite term that includes rash maculo-papular, rash, dermatitis, dermatitis acneiform, erythema, rash pruritic, dermatitis bullous, dyshidrotic eczema, pemphigoid, rash erythematous, and urticaria.1
  • ||Upper respiratory tract infection is a composite term that includes upper respiratory tract infection, nasopharyngitis, rhinitis, sinusitis, pharyngitis, respiratory tract infection, and viral upper respiratory tract infection.1
  • Dyspnea is a composite term that includes dyspnea and dyspnea exertional.1
  • #Hypertension is a composite term that includes hypertension and hypertensive crisis.1

LIBTAYO was validated in the largest prospective clinical trial of patients with laBCC previously treated
with an HHI1


Study 1620 was an open-label, multicenter, phase 2, nonrandomized study that included 132 patients, of which 84 patients had laBCC that had progressed on HHI therapy, had not had an objective response after 9 months on HHI therapy, or were intolerant of prior HHI therapy. Patients received 350 mg every 3 weeks for 5 cycles of 9 weeks followed by 4 cycles of 12 weeks up to 93 weeks. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment. Tumor response assessments were conducted every 9 weeks (during cycles 1 to 5) and then every 12 weeks (during cycles 6 to 9).1,2

The primary efficacy endpoint was confirmed ORR by ICR. Selected secondary endpoints included complete response rate, DOR, and safety and tolerability.1,2

The study 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

  • ORR is determined by the proportion of patients with best objective response of CR or PR based on independent central-reviewed evaluation, as determined by RECIST version 1.1 for radiologic assessments, or by modified WHO Criteria for photographic assessments, or by the composite response criteria for patients assessed by both radiology and photography.2
  • CR is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to be a CR and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; patients with laBCC in the study required biopsy to confirm CR.2
  • PR is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. PR of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest diameters of target lesions, per WHO Criteria. Nontarget lesions could not have PD, and there could be no new lesions. Responses had to be maintained for at least 4 weeks.2
  • CR=complete response; DOR=duration of response; ICR=independent central review; NE=not evaluable; ORR=objective response rate; PD=progressive disease; PD-1=programmed death receptor-1; PD-L1=programmed death ligand 1; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease; TMB=tumor mutational burden; WHO=World Health Organization.

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.