Table 2 Best responses overall and by disease status in 52 patients treated with naxitamab plus GM-CSF

From: The anti-GD2 monoclonal antibody naxitamab plus GM-CSF for relapsed or refractory high-risk neuroblastoma: a phase 2 clinical trial

Patient population

Endpoint

Patients

n (%)

95% CI, %

Overall (N = 52)

CR

20 (39)

25–53

PR

6 (12)

4–23

MR

5 (10)

3–21

SD

10 (19)

10–33

PD

8 (15)

7–28

NE

3 (6)

–

ORR

CR + PR

26 (50)

36–64

Disease status

Refractory neuroblastoma (n = 26)

CR

12 (46)

27–67

PR

3 (12)

2–30

MR

3 (12)

2–30

SD

3 (12)

2–30

PD

4 (15)

4–35

NE

1 (4)

–

ORR

CR + PR

15 (58)

37–77

Relapsed neuroblastoma (n = 26)

CR

8 (31)

14–52

PR

3 (12)

2–30

MR

2 (8)

1–25

SD

7 (27)

11–48

PD

4 (15)

4–35

NE

2 (8)

–

ORR

CR + PR

11 (42)

23–63

  1. Best response according to independent review, based on INRC (efficacy population).
  2. CR complete response, GM-CSF granulocyte-macrophage colony-stimulating factor, INRC International Neuroblastoma Response Criteria, MD minimal disease, MR minor response, NE not evaluable, ORR overall response rate, PD progressive disease, PR partial response, SD stable disease.
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