Table 2 Summary of safety and AESIs

From: Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial

Parameter, n (%)a

Axi-cel + rituximab (n = 26)

Any grade

Grade ≥3

Any AE

26 (100)

24 (92)

Any AE related to:

 Leukapheresis

2 (8)

0

 Lymphodepleting chemotherapy

23 (88)

20 (77)

Any TEAE

26 (100)

24 (92)

Any TEAE related to:

 Rituximab only

5 (19)

1 (4)

 Axi-cel only

25 (96)

8 (31)

 Both axi-cel and rituximab

4 (15)

3 (12)

Any SAE

14 (54)

11 (42)

Any SAE related to:

 Rituximab only

0

0

 Axi-cel only

6 (23)

3 (12)

 Both axi-cel and rituximab

1 (4)

1 (4)

AESIs

CRSb

25 (96)

0

Neurologic event

16 (62)

4 (15)

Any prolonged cytopenia

14 (54)

10 (38)

 Prolonged anemia

5 (19)

4 (15)

 Prolonged neutropenia

12 (46)

9 (35)

 Prolonged thrombocytopenia

3 (12)

3 (12)

Bacterial infection

1 (4)

0

Hypogammaglobulinemia

6 (23)

0

Secondary malignancy

2 (8)

2 (8)c

  1. Safety analysis population (all participants treated with axi-cel). MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE.
  2. aAEs and TEAEs were coded per MedDRA version 25.1 and graded per CTCAE version 5.0.
  3. bOverall CRS was graded per the revised grading system proposed in ref. 43.
  4. cBoth events were grade 5.
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