Advanced NSCLC Combination Treatment

Safety Profile

LIBTAYO safety profile in EMPOWER-Lung 31,2

Adverse reactions in ≥10% of patients1,2

Adverse reactions
LIBTAYO +
chemotherapy (n=312)
All Grades,
%
Grades 3-4,
%
Chemotherapy
(n=153)
All Grades,
%
Grades 3-4,
%
Skin and subcutaneous tissue disorders
Alopecia
37
0
43
0
Rash*
13
1.3
6
0
 
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
30
1.6
36
0
 
Gastrointestinal disorders
Nausea
25
0
16
0
Constipation
14
0.3
11
0
Vomiting
12
0
10
0
Diarrhea
11
1.3
7
0
 
General disorders and administration site conditions
Fatigue
23
3.8
18
2
 
Nervous system disorders
Peripheral neuropathy§
23
0
19
0
 
Metabolism and nutrition disorders
Decreased appetite
17
1
12
0
 
Investigations
Weight decreased
11
1.3
8
0
 
Respiratory, thoracic, and mediastinal disorders
Dyspnea||
13
2.2
7
0.7
 
Psychiatric disorders
Insomnia
11
0
7
0
 
  • *Rash is a composite term that includes rash, rash maculopapular, dermatitis, psoriasis, rash papular, urticaria, dermatitis allergic, erythema, lichen planus, rash macular, rash pruritic, skin reaction, skin toxicity, skin exfoliation, and dermatitis acneiform.
  • Musculoskeletal pain is a composite term that includes arthralgia, back pain, pain in extremity, noncardiac chest pain, myalgia, bone pain, musculoskeletal pain, neck pain, musculoskeletal chest pain, arthritis, and spinal pain.
  • Fatigue is a composite term that includes asthenia, fatigue, and malaise.
  • §Peripheral neuropathy is a composite term that includes peripheral sensory neuropathy, peripheral neuropathy, paresthesia, polyneuropathy, hypoaesthesia, peripheral sensorimotor neuropathy, neuralgia, polyneuropathy in malignant disease, and toxic neuropathy.
  • ||Dyspnea is a composite term that includes dyspnea and dyspnea exertional.
  • Toxicity was graded per National Cancer Insititute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
  • Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions that occurred in at least 2% of patients were pneumonia, anemia, and neutropenia1
  • Fatal adverse reactions occurred in 6% of patients who received LIBTAYO in combination with chemotherapy [including death not otherwise specified (2.9%), sudden death (1.0%), acute hepatitis (0.3%), acute respiratory distress syndrome (0.3%), mesenteric artery thrombosis (0.3%), pneumonia (0.3%), pneumonitis (0.3%), and pulmonary hemorrhage (0.3%)] vs 7.8% with chemotherapy alone1
  • Adverse reactions resulting in permanent discontinuation in at least 2 patients were increased alanine aminotransferase and anemia1
  • Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 33% of patients. Adverse reactions that required dosage interruptions in at least 2% of patients were anemia, pneumonia, neutropenia, thrombocytopenia, fatigue, COVID-19 infection, and pyrexia1
  • The most common (≥15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite1
Permanent discontinuation rates due to adverse reactions
5%
LIBTAYO + chemotherapy
2.6%
Chemotherapy alone

Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients1,2

Laboratory abnormalities
LIBTAYO + chemotherapy (n=312)
Chemotherapy (n=153)
Grades 3-4, %*
Chemistry
Hyperglycemia
4
1.5
Increased alanine aminotransferase
3
2.1
Increased creatinine
2
1.4
Hypoalbuminemia
1
0
 
Hematology
Anemia
10
7
Neutrophil count decreased
10
8
Lymphocyte count decreased
7
8
White blood cell decreased
6
4.1
Platelet count decreased
4.7
0.7
 
Electrolytes
Hyponatremia
6
4.1
Hypophosphatemia
3.4
7
Hypocalcemia
3
2.1
Hyperkalemia
2.7
2.7
Hypermagnesemia
2.4
2.8
Hypokalemia
2.3
1.4
Hypercalcemia
1.7
0.7
Hypernatremia
1
0
 
  • *Percentages are based on the number of patients with at least 1 postbaseline value available for that parameter.
  • Toxicity graded per NCI CTCAE v4.03.
  • NCI CTCAE=National Cancer Insititute Common Terminology Criteria for Adverse Events
  • The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were anemia, neutropenia, lymphopenia, leukopenia, hyponatremia, thrombocytopenia, hyperglycemia, hypophosphatemia, increased alanine aminotransferase, hypocalcemia, hyperkalemia, hypermagnesemia, hypokalemia, and increased creatinine1