Table 1 Patient populations, treatment arms and efficacy outcomes of the Phase III DREAMM-3, DREAMM-7, and DREAMM-8 trials.

From: The clinical journey of belantamab mafodotin in relapsed or refractory multiple myeloma: lessons in drug development

Patient population

DREAMM-3

DREAMM-7

DREAMM-8

Primary Analysis [14]

Updated Analysis [32]

Interim Analysis [18]

2nd Interim Analysis [17]

RRMM with ≥2 prior LOTs including immunomodulatory drug and PI

RRMM with ≥1 prior LOT but not refractory to anti-CD38 therapy

RRMM with ≥1 prior LOT including lenalidomide

Treatment arms

Belantamab mafodotin 2.5 mg/kg Q3W (n = 218)

Pd (n = 107)

Belantamab mafodotin 2.5 mg/kg Q3W (n = 218)

Pd (n = 107)

Belantamab mafodotin 2.5 mg/kg Q3W + Vd (n = 243)

DVd (n = 251)

Belantamab mafodotin 2.5 mg/kg Q4W for Cycle 1 then 1.9 mg/kg Q4W from Cycle 2 onwards + Pd (n = 155)

PVd (n = 147)

Efficacy

Median (range) follow-up, mo

11.5 (5.5–17.6)

10.8 (5.6–17.1)

22.4 (0.6–43.0)

21.9 (0.0–44.2)

28.2 (0.1–40.0)

 

22.4 ( < 0.1–36.4)

20.5 (0.1–39.2)

PFS

Median (95% CI), mo

11.2 (6.4–14.5)

7.0 (4.6–10.6)

–

–

36.6 (28.4–NR)

13.4 (11.1–17.5)

NR

12.7 (9.1–18.5)

PFS rate

–

–

–

–

69% at 18 mo

43% at 18 mo

71% at 12 mo

51% at 12 mo

HR (95% CI); P-value

1.03 (0.72–1.47); P = 0.56

 

0.86 (0.63–1.18)

 

0.41 (0.31–0.53); P < 0.001

 

0.52 (0.37–0.73); P < 0.001

 

OS

Median (95% CI), mo

21.2 (18.7–NR)a

21.1 (15.1–NR)a

–

–

33.9 (21.9–NR)b

15.2 (12.3–21.1)b

19.0 (12.2–23.3)c

12.7 (8.0–18.5)c

OS rate

–

–

–

–

84% at 18 mo

73% at 18 mo

83% at 12 mo

76% at 12 mo

HR (95% CI); P-value

1.14 (0.77–1.68); P = 0.75

 

0.93 (0.69–1.26)

 

0.57 (0.40–0.80)

 

0.77 (0.53–1.14)

 

ORR, %

41

36

41

36

83

71

77

72

sCR/CR

10

3

–

–

35

17

40

16

≥ VGPR

25

8

–

–

66

46

64

38

PR

16

28

–

–

17

25

14

34

CBR ( ≥ MR)

47

47

–

–

86

76

80

78

Median (range) duration of response, mo

NR (17.9–NR)

8.5 (7.6–NR)

24.9 (20.7–32.5)

10.4 (7.6–20.0)

35.6 (30.5–NR)

17.8 (13.8–23.6)

–

–

  1. aData on OS were 38% immature at data cutoff (September 12, 2022).
  2. bData on OS were 29% mature at cutoff (October 2, 2023). 25th percentile of the distribution of OS duration is shown; follow-up for OS is ongoing.
  3. cData on OS were 35% mature (as of January 29, 2024). 25th percentile of the distribution of OS duration is shown; follow-up for OS is ongoing.
  4. CBR clinical benefit rate, CI confidence interval, CR complete response, DVd daratumumab, bortezomib and dexamethasone, HR hazard ratio, LOT line of therapy, mo months, MR minimal response, NR not reached, ORR overall response rate, OS overall survival, Pd pomalidomide and dexamethasone, PFS progression-free survival, PI proteosome inhibitor, PR partial response, PVd pomalidomide, bortezomib and dexamethasone, Q3W every 3 weeks, Q4W every 4 weeks, RRMM relapsed/refractory multiple myeloma, sCR stringent complete response; VGPR very good partial response.
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