Advanced NSCLC Monotherapy Treatment

Safety Profile

LIBTAYO safety profile in EMPOWER-Lung 11

Adverse reactions in ≥10% of patients1

Adverse reactions
LIBTAYO (n=355)
All Grades, %
Grades 3-4, %
Chemotherapy (n=342)
All Grades, %
Grades 3-4, %
Musculoskeletal and connective tissue disorders
Musculoskeletal pain*
26
0.6
27
1.5
 
Skin and subcutaneous tissue disorders
Rash
15
1.4
6
0
 
Blood and lymphatic system disorders
Anemia
15
3.4
50
16
 
General disorders and administration site conditions
Fatigue
14
1.1
26
2
 
Metabolism and nutrition disorders
Decreased appetite
12
0.6
18
0.3
 
Infections and infestations
Pneumonia§
11
5
12
5
 
Respiratory, thoracic, and mediastinal disorders
Cough||
11
0
8
0.3
 
  • *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.
  • Serious adverse reactions occurred in 28% of patients receiving LIBTAYO1,2
  • The most frequent serious adverse reaction in at least 2% of patients was pneumonia1,2
  • Adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke, and increased aspartate aminotransferase1,2
Permanent discontinuation rates due to adverse reactions
6%
LIBTAYO
4%
Chemotherapy alone

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

Laboratory abnormalities
LIBTAYO + chemotherapy (n=355)
Chemotherapy (n=342)
Grades 3-4, %*
Chemistry
Increased aspartate 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
 
Hematology
Lymphopenia
7
9
Anemia
2.7
16
 
Electrolytes
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
 
  • *Percentages are based on the number of patients with at least 1 postbaseline value available for that parameter.
  • Toxicity was graded per NCI CTCAE v4.03.