LIBTAYO demonstrated a favorable safety profile in patients with advanced cutaneous squamous cell carcinoma (CSCC) in clinical studies1

Adverse reactions in ≥10% of patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation receiving LIBTAYO in Study 1423 and Study 15401

Adverse reactions LIBTAYO N=219
All grades,
%
Grade 3-4,
%
General and administration site
Fatiguea 34 3
Skin and subcutaneous tissue
Rasha 31 1
Pruritusb 18 0
Gastrointestinal
Diarrheac 25 0.5
Nausea 21 0
Constipation 13 0.5
Vomiting 10 0.5
Musculoskeletal and connective tissue
Musculoskeletal paine 24 3
Arthralgia 11 1
Respiratory
Coughf 14 0
Hematology
Anemia 11 4
Endocrine
Hypothyroidism 10 0
Metabolism and nutrition
Decreased appetite 10 0
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
  • a Fatigue is a composite term that includes fatigue and asthenia.
  • b 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.
  • c Pruritus is a composite term that includes pruritus and pruritus allergic.
  • d Diarrhea is a composite term that includes diarrhea and colitis.
  • eMusculoskeletal pain is a composite term that includes back pain, pain in extremity, myalgia, musculoskeletal pain, and neck pain.
  • f Cough is a composite term that includes cough and upper airway cough syndrome.

  • The most common grade 3-4 adverse reactions (≥2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia
  • LIBTAYO was permanently discontinued due to adverse reactions in 8% of patients
  • 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 state
  • Serious adverse reactions occurred in 35% of patients
  • Serious adverse reactions that occurred in at least 2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia


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; 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.



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

Laboratory abnormalities Combined (N = 219)
Grade 3-4, %a
Chemistry
Increased aspartate aminotransferase 2
Increased INR 2
Hematology
Lymphopenia 9
Anemia 5
Electrolytes
Hyponatremia 5
Hypophosphatemia 4
Hypercalcemia 2
  • Toxicity graded per NCI CTCAE v4.03.
  • a Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.
  • INR, international normalized ratio.
The safety of LIBTAYO was evaluated in 534 patients with advanced solid malignancies, including 219 patients with advanced CSCC.1

Indication and Usage

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

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