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; 2024.

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; 2024. 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.