In adult patients with R/R B-cell precursor ALL
Well-characterized safety profile with TECARTUS® in the primary analysis of ZUMA-31
Adverse reactions
Summary of adverse
reactions observed in ≥10%
of patients
treated with
TECARTUS in ZUMA-3
(N=78)1
Adverse
Reactions
Any Grade (%)
Grade ≥3 (%)
Blood and Lymphatic System Disorders
Febrile Neutropenia
Coagulopathy
Cardiac Disorders
35
17
35
5
Tachycardias
Arrhythmia
63
15
6
1
Gastrointestinal Disorders
Nausea
Diarrhea
Abdominal pain
Constipation
Vomiting
41
32
19
24
21
1
6
0
0
3
General Disorders and
Administration
Site Conditions
Fever
Chills
Edema
Fatigue
Pain
96
40
29
37
13
38
0
5
1
1
Immune System Disorders
Cytokine release
syndrome
92
26
Infections and Infestations
Infections with
pathogen unspecified
Bacterial infections
Fungal infections
28
15
13
22
8
5
Metabolism and Nutrition Disorders
Decreased appetite
22
1
Musculoskeletal and Connective
Tissue
Disorders
Musculoskeletal pain
Muscular weakness
32
14
5
1
Nervous System Disorders
Encephalopathy
Headache
Tremor
Dizziness
63
38
29
13
27
1
1
1
Psychiatric Disorders
Delirium
Anxiety
Insomnia
18
12
13
5
0
0
Respiratory, Thoracic, and
Mediastinal
Disorders
Hypoxia
Cough
Dyspnea
31
12
12
23
0
1
Skin and Subcutaneous
Tissue Disorders
Rash
31
0
Vascular Disorders
Hypotension
Hemorrhage
Hypertension
69
13
13
33
4
6
Pinch to zoom
Four Grade 5 adverse events occurred with TECARTUS1
ALL=acute lymphoblastic leukemia; R/R=relapsed or refractory.
Reference: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021.
Grade 3 or 4 lab abnormalities
Grade 3 or 4 laboratory
abnormalities occurring in
≥10% of
patients in
ZUMA-2 following
TECARTUS infusion
(N=78)1
Grade 3 or 4 (%)
Leukopenia
99
Neutropenia
97
Lymphopenia
96
Thrombocytopenia
87
Anemia
77
Hypophosphatemia
47
Alanine aminotransferase increased
31
Aspartate aminotransferase increased
23
Hyperglycemia
22
Hypocalcemia
22
Blood uric acid increased
19
Direct bilirubin increased
19
Hyponatremia
16
Hypokalemia
13
Hyperbilirubinemia
10
Pinch to zoom
Prolonged cytopenias have occurred following treatment with TECARTUS1
- Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion
- At Day 30, 20% (n=7/35) of patients who responded had unresolved Grade 3 or higher cytopenias
- 12% with thrombocytopenia
- 12% with neutropenia
The 3-year safety analysis was consistent with the primary safety analysis2,3
- In the primary analysis, four Grade 5 adverse events occurred with TECARTUS. Of the 4 patients who had fatal adverse events: one patient with fatal pneumonia had pre-existing pneumonia prior to study enrollment, and one patient with fatal sepsis had prolonged cytopenia and immunosuppression from prior therapies and underlying disease1
ALL=acute lymphoblastic leukemia; R/R=relapsed or refractory.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Shah BD, Ghobadi A, Oluwole OO, et al. Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study. J Hematol Oncol. 2022;15(1):170. Published online December 10, 2022. doi:10.1186/s13045-022-01379-0 3. Hadjivassileva T, Shah BD, Ghobadi A, et al. Three-year follow-up of brexucabtagene autoleucel, an anti-CD19 chimeric antigen receptor T-cell therapy, in adults with relapsed/refractory B-cell acute lymphoblastic leukemia in ZUMA-3. Poster 34. Poster presented at the 5th European CAR T‑cell Meeting; February 9-11, 2023; Rotterdam, The Netherlands.