Advanced NSCLC Monotherapy Treatment

Safety Profile

LIBTAYO demonstrated a favorable safety profile in EMPOWER-Lung 11

Adverse reactions in >10% of patients1

Adverse reactions in ≥10% of patients
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.1

For more information on Warnings and Precautions, see additional Important Safety Information below and in Section 5 of the full Prescribing Information.
  • *Musculoskeletal pain is a composite term that includes back pain, arthralgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, bone pain, myalgia, neck pain, spinal pain, and musculoskeletal stiffness.
  • Rash is a composite term that includes rash, dermatitis, urticaria, rash maculopapular, erythema, rash erythematous, rash pruritic, psoriasis, autoimmune dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, drug eruption, dyshidrotic eczema, lichen planus, and skin reaction.
  • Fatigue is a composite term that includes fatigue, asthenia, and malaise.
  • §Pneumonia is a composite term that includes atypical pneumonia, embolic pneumonia, lower respiratory tract infection, lung abscess, paracancerous pneumonia, pneumonia, pneumonia bacterial, and pneumonia klebsiella.
  • ||Cough is a composite term that includes cough and productive cough.
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
  • HSCT=hematopoietic stem cell transplantation.

  • LIBTAYO was permanently discontinued due to adverse events in 6% of patients1
  • Adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke, and increased aspartate aminotransferase1
  • Serious adverse reactions occurred in 28% of patients receiving LIBTAYO1
  • The most frequent serious adverse reactions in at least 2% of patients were pneumonia and pneumonitis1

Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients1

Laboratory abnormalities
LIBTAYO (n=355)
Chemotherapy
(n=342)
Grade 3-4, %*
Chemistry
Increase aspertate aminotransferase
3.9
1.2
Increased alanine aminotransferase
2.7
0.3
Increased alkaline phosphatase
2.4
0.3
Increased blood bilirubin
2.1
0.3
Hypoalbuminemia
1.8
1.3
Increased creatinine
1.2
1.6
 
Lymphopenia
7
9
Anemia
2.7
16
 
Hyponatremia
6
7
Hyperkalemia
4.2
1.9
Hypocalcemia
3.9
3.4
Hypophosphatemia
2.4
4.1
Hypermagnesemia
2.1
1.6
Hypokalemia
1.5
2.2
Hypercalcemia
1.2
2.2
 

Reference: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc.