Tables 10 and 11 summarize adverse reactions and laboratory abnormalities in patients receiving TECENTRIQ with bevacizumab, paclitaxel, and carboplatin in IMpower150.
Table 10: Adverse Reactions Occurring in ≥15% of Patients with NSCLC Receiving TECENTRIQ in IMpower150
TECENTRIQ with Bevacizumab, Paclitaxel, and Carboplatin
Adverse Reaction
Nervous System Neuropathy1 Headache
General Fatigue/Asthenia
Skin and Subcutaneous Tissue Alopecia Rash2
N = 393
All Grades (%)
56 16
Pyrexia 19
Grades 3–4 (%)
3 0.8
Bevacizumab, Paclitaxel and Carboplatin
N = 394
All Grades (%)
47 13
9
Grades 3–4 (%)
3 0
50 6466 0.3
48 23
Musculoskeletal and Connective Tissue Myalgia/Pain3
42 Arthralgia 26
Gastrointestinal Nausea
Diarrhea4
Constipation Vomiting
Metabolism and Nutrition Decreased appetite
Respiratory Cough
Epistaxis
Renal Proteinuria5
Graded per NCI CTCAE v4.0 1
2 3
39 33 30 19
29
Vascular Hypertension 25
20 17
16
0 2
3 1
4 6
0.3 2
4 9
0.8 1
3
46 10
34 22
32 25 23 18
21 22
19 22
15
Includes neuropathy peripheral, peripheral sensory neuropathy, hypoesthesia, paraesthesia, dysesthesia, polyneuropathy
Includes rash, rash maculo-papular, drug eruption, eczema, eczema asteatotic, dermatitis, contact dermatitis, rash erythematous, rash macular, pruritic rash, seborrheic dermatitis, dermatitis psoriasiform
Includes pain in extremity, musculoskeletal chest pain, musculoskeletal discomfort, neck pain, back pain, myalgia, and bone pain
4 Includes diarrhea, gastroenteritis, colitis, enterocolitis 5 Data based on Preferred Terms since laboratory data for proteinuria were not systematically collected
Table 11: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients with NSCLC Receiving TECENTRIQ in IMpower150
Laboratory Abnormality
Hematology Anemia
Neutropenia Lymphopenia
Chemistry Hyperglycemia Increased BUN
Hypomagnesemia Hypoalbuminemia Increased AST Hyponatremia
Increased Alkaline Phosphatase
Increased ALT Increased TSH Hyperkalemia
Increased Creatinine Hypocalcemia
Hypophosphatemia Hypokalemia
Hyperphosphatemia
Bevacizumab, Paclitaxel, and Carboplatin
All Grades (%)
83 52 48
61 52 42 40 40 38
37 37
30 28 28 26 25 23 25
Grades 3–4 (%)
10 31 17
0
NA1 2 3 4
10 2 6
NA1 3 1
TECENTRIQ with
Bevacizumab, Paclitaxel and Carboplatin
All Grades (%)
83 45 38
60 44 36 31 28 36
32 28
20 25 19
NA1
paclitaxel, and carboplatin (range: 337-382). Graded per NCI CTCAE v4.0 1
18 14 19
Grades 3–4 (%)
9
26 13
Laboratory Abnormality 0
NA1 1 2
0.8 9
1
0.5 NA1 2 2
3213 4 7
4 4
NA1
Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ with bevacizumab, paclitaxel, and carboplatin range: 337-380); bevacizumab,
NA = Not applicable. NCI CTCAE does not provide a Grades 3-4 definition for these laboratory abnormalities
IMpower130 The safety of TECENTRIQ with paclitaxel protein-bound and carboplatin was evaluated in IMpower130, a multicenter, international, randomized, open-label trial in which 473 chemotherapy-naïve patients with metastatic non-squamous NSCLC received TECENTRIQ 1200 mg and carboplatin AUC 6 mg/mL/min intravenously on Day 1 and paclitaxel protein-bound 100 mg/m2
each 21-day cycle for a maximum of 4 or 6 cycles, followed by TECENTRIQ 1200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity [see Clinical Studies (14.2)].
intravenously on Day 1, 8, and 15 of
Hematology Anemia
Neutropenia
Thrombocytopenia Lymphopenia
Chemistry Hyperglycemia
Hypomagnesemia Hyponatremia
Hypoalbuminemia Increased ALT Hypocalcemia
Hypophosphatemia Increased AST Increased TSH Hypokalemia
Increased Alkaline Phosphatase
Increased Blood Creatinine Hyperphosphatemia
2 0 0.3
2 1
2
0.5 0.3 1
0.8 8
0.3 0.3
3 Adverse Reaction
General Fatigue/Asthenia
Gastrointestinal Nausea
Diarrhea1
Constipation Vomiting
Nervous System Neuropathy3
0.5
Among patients receiving TECENTRIQ, 55% were exposed for 6 months or longer and 3.5% were exposed for greater than one year.
Fatal adverse reactions occurred in 5.3% of patients receiving TECENTRIQ; these included pneumonia (1.1%), pulmonary embolism (0.8%), myocardial infarction (0.6%), cardiac arrest (0.4%), pneumonitis (0.4%) and sepsis, septic shock, staphylococcal sepsis, aspiration, respiratory distress, cardiorespiratory arrest, ventricular tachycardia, death (not otherwise specified), and hepatic cirrhosis (0.2% each).
Serious adverse reactions occurred in 51% of patients receiving TECENTRIQ. The most frequent serious adverse reactions (≥2%) were pneumonia (6%), diarrhea (3%), lung infection (3%), pulmonary embolism (3%), chronic obstructive pulmonary disease exacerbation (2.5%), dyspnea (2.3%), and febrile neutropenia (1.9%).
TECENTRIQ was discontinued due to adverse reactions in 13% of patients; the most common adverse reactions leading to discontinuation were pneumonia (0.8%), pulmonary embolism (0.8%), fatigue (0.6%), dyspnea (0.6%), pneumonitis (0.6%), neutropenia (0.4%), nausea (0.4%), renal failure (0.4%), cardiac arrest (0.4%), and septic shock (0.4%).
Adverse reactions leading to interruption of TECENTRIQ occurred in 62% of patients; the most common (>1%) were neutropenia, thrombocytopenia, anemia, diarrhea, fatigue/asthenia, pneumonia, dyspnea, pneumonitis, pyrexia, nausea, acute kidney injury, vomiting, pulmonary embolism, arthralgia, infusion- related reaction, abdominal pain, chronic obstructive pulmonary disease exacerbation, dehydration, and hypokalemia.
Tables 12 and 13 summarize adverse reactions and laboratory abnormalities in patients receiving TECENTRIQ with paclitaxel protein-bound and carboplatin in IMpower130.
Table 12: Adverse Reactions Occurring in ≥20% of Patients with NSCLC Receiving TECENTRIQ in IMpower130
Paclitaxel Protein-Bound and Carboplatin N = 473
All Grades (%)
61
50 43 36 27
Musculoskeletal and Connective Tissue Myalgia/Pain2
38 33
Respiratory, Thoracic and Mediastinal Dyspnea4 Cough
Skin and Subcutaneous Tissue Alopecia Rash5
Metabolism and Nutrition Decreased appetite
Graded per NCI CTCAE v4.0 1
Includes diarrhea, colitis, and gastroenteritis
Includes back pain, pain in extremity, myalgia, musculoskeletal chest pain, bone pain, neck pain and musculoskeletal discomfort
3 Includes neuropathy peripheral, peripheral sensory neuropathy, hypoesthesia, paresthesia, dysesthesia, polyneuropathy 4 Includes dyspnea, dyspnea exertional and wheezing
5
Includes rash, rash maculo-papular, eczema, rash pruritic, rash erythematous, dermatitis, dermatitis contact, drug eruption, seborrheic dermatitis and rash macular.
Table 13: Laboratory Abnormalities Worsening from Baseline Occurring in ≥20% of Patients Receiving TECENTRIQ in IMpower130
Paclitaxel Protein-Bound and Carboplatin N = 473
All Grades (%)
92 75 73 71
75 50 37 35 31 31 29 28 26 26
25 23
21
Grades 3–4 (%)
33 50 19 23
8
3.4 9
1.3 2.8 2.6 6
2.2 NA1 6
2.6 2.8
NA1
bound and carboplatin (range: 218 - 229). Graded per NCI CTCAE v4.0. 1
TECENTRIQ with
Paclitaxel Protein-Bound and Carboplatin N = 232
All Grades (%)
87 67 59 61
66 42 28 31 24 27 20 24
24 22 16
13
Grades 3–4 (%)
25 39 13 16
8
3.2 7 0
3.9 1.8 3.2 1.8
5NA1 4.4
1.3 0.4
NA1
Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TECENTRIQ with paclitaxel protein-bound and carboplatin (range: 423 - 467); paclitaxel protein-
NA = Not applicable. NCI CTCAE does not provide a Grades 3-4 definition for these laboratory abnormalities
32 27
32 20
30
Grades 3–4 (%)
11 3.4
1.1 2.7
3 2.5
4.9 0.6
0 0.6 2.1 TECENTRIQ with
Paclitaxel Protein-Bound and Carboplatin N = 232
All Grades (%)
60 46
Grades 3–4 (%)
8 2.2
6326 31 19
0 2.2 22 28
25 17
27 11
26 0.4 2.2
1.3 0
0 0.9 2.2
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