Selected safety information1

The safety data described below reflect exposure to LIBTAYO in 163 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1423 and Study 1540. The safety population characteristics were: median age of 71 years (38 to 96 years), 85% male, 96% white, and ECOG performance score (PS) of 0 (44%) or 1 (56%).

Adverse reactions in ≥10% of advanced cutaneous squamous cell carcinoma (CSCC) patients receiving LIBTAYO in Study 1423 and 1540

Adverse reactions Combined (N = 163)
All grades,
%
Grade 3-4,
%
Skin and subcutaneous tissue
Rasha 25 1.2
Pruritusb 15 0
Gastrointestinal
Diarrheac 22 0.6
Nausea 19 0
Constipation 12 0.6
General disorders and administration site
Fatigued 29 2
Musculoskeletal and connective tissue
Musculoskeletal paine 17 3
Metabolism and nutrition
Decreased appetite 10 0
  • a Rash is a composite term that includes rash maculopapular, rash, dermatitis, rash generalized, dermatitis bullous, drug eruption, erythema, rash erythematous, rash macular, rash pruritic, and skin reaction.
  • b Pruritus is a composite term that includes pruritus and pruritus allergic.
  • c Diarrhea is a composite term that includes diarrhea and colitis.
  • d Fatigue is a composite term that includes fatigue and asthenia.
  • e Musculoskeletal pain is a composite term that includes musculoskeletal pain, back pain, myalgia, neck pain, and pain in extremity.

  • The most common grade 3-4 adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia, musculoskeletal pain, skin infection, urinary tract infection, and fatigue
  • LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients
  • Adverse reactions resulting in permanent discontinuation were pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex regional pain syndrome, cough, and muscular weakness
  • Serious adverse reactions occurred in 28% of patients
  • Serious adverse reactions that occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis, and urinary tract infection

Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients with advanced CSCC receiving LIBTAYO in Studies 1423 and 1540

Laboratory abnormalities Combined (N = 163)
Grade 3-4, %a
Chemistry
Increased aspartate aminotransferase 3
Increased INR 2
Hypoalbuminemia 1
Hematology
Lymphopenia 7
Anemia 2
Electrolytes
Hypophosphatemia 4
Hyponatremia 3
Hypercalcemia 1
  • a Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.
  • INR, international normalized ratio.

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