LIBTAYO demonstrated a favorable safety profile in patients with advanced CSCC in clinical studies1

Adverse reactions in ≥10% of patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation and who received LIBTAYO in Study 1423 and Study 15401

Chart, adverse reactions in clinical study 1423 and 1540: mCSCC or laCSCC (N=219)


Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

  • The most common Grade 3-4 adverse reactions (≥2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia1
  • LIBTAYO was permanently discontinued due to adverse reactions in 8% of patients1
  • Adverse reactions resulting in permanent discontinuation were pneumonitis, cough, pneumonia, encephalitis, aseptic meningitis, hepatitis, arthralgia, muscular weakness, neck pain, soft tissue necrosis, complex regional pain syndrome, lethargy, psoriasis, rash maculopapular, proctitis, and confusional state1
  • Serious adverse reactions occurred in 35% of patients1
  • Serious adverse reactions that occurred in at least 2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia1

Warnings and Precautions for LIBTAYO1

Warnings and Precautions for LIBTAYO include severe and fatal immune-mediated adverse reactions such as immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic HSCT; and embryo-fetal toxicity. Monitor for symptoms and signs of immune-mediated adverse reactions.

For more information on Warnings and Precautions, see additional Important Safety Information below and in Section 5 of the full Prescribing Information.

  • *Fatigue is a composite term that includes fatigue and asthenia.1
  • Rash is a composite term that includes rash, rash maculopapular, erythema, dermatitis, dermatitis bullous, rash generalized, pemphigoid, rash erythematous, rash macular, rash pruritic, drug eruption, psoriasis, and skin reaction.1
  • Pruritus is a composite term that includes pruritus and pruritusallergic.
  • §Diarrhea is a composite term that includes diarrhea and colitis.1
  • IIMusculoskeletal pain is a composite term that includes back pain, pain in extremity, myalgia, musculoskeletal pain, and neck pain.1
  • Cough is a composite term that includes cough and upper airway cough syndrome.1
  • CR=complete response; CSCC=cutaneous squamous cell carcinoma; HSCT=hematopoietic stem cell transplantation; laCSCC=locally advanced CSCC; mCSCC=metastatic CSCC.

Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation receiving LIBTAYO in Study 1423 and Study 15401

Chart, laboratory abnormalities in clinical study 1423 and 1540: mCSCC or laCSCC (N=219)
  • #Percentages are based on the number of patients with at least 1 postbaseline value available for that parameter.1
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.1

Reference: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron PharmaceuticaIs, Inc., and sanofi-aventis U.S. LLC.