Table 4 Best responses by CS at enrollment and prior anti-GD2 mAb treatment 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, %

Response by CS at enrollment

CS ≤ 2 (n = 22)

CR

10 (45)

24–68

PR

1 (5)

0–23

MR

2 (9)

1–29

SD

7 (32)

14–55

PD

2 (9)

1–29

ORR

CR + PR

11 (50)

28–72

CS ≥ 3 (n = 30)

CR

10 (33)

17–53

PR

5 (17)

6–35

MR

3 (10)

2–27

SD

3 (10)

2–27

PD

6 (20)

8–39

NE

3 (10)

–

ORR

CR + PR

15 (50)

31–69

Response by prior anti-GD2 mAb

No prior anti-GD2 mAb (n = 39)

CR

17 (44)

28–60

PR

5 (13)

4–27

MR

4 (10)

3–24

SD

6 (15)

6–31

PD

4 (10)

3–24

NE

3 (8)

–

ORR

CR + PR

22 (56)

40–72

Prior anti-GD2 mAb (n = 13)

CR

3 (23)

5–54

PR

1 (8)

0–36

MR

1 (8)

0–36

SD

4 (31)

9–61

PD

4 (31)

9–61

ORR

CR + PR

4 (31)

9–61

  1. Best response according to independent review, based on INRC (efficacy population).
  2. CR complete response, CS Curie score, GM-CSF granulocyte-macrophage colony-stimulating factor, INRC International Neuroblastoma Response Criteria, mAb monoclonal antibody, 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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