Table 1 Phase II and III trials of brentuximab vedotin (BV)

From: Understanding CD30 biology and therapeutic targeting: a historical perspective providing insight into future directions

Trial

Phase

Disease subgroup

Patient number

Median age in years (range)

Response rates

Response duration

Survival

Pro et al.83

II

sALCL

58

52 (14–76)

ORR 86% (95% CI 74.6–93.9)

CR 57% (95% CI 43.2–69.8)

PR 29%

Median DOR 12.6 months (95% CI 5.7–NE)

Median PFS 13.3 months (95% CI 6.9–NE)

Median OS not reached

Younes et al.84

II

HL

102

31 (15–77)

ORR 75% (95% CI 64.9%–82.6%)

CR 34% (95% CI 25.2%–44.4%)

PR 40%

Median DOR 6.7 months (95% CI 3.6–14.8)

Median PFS 5.6 months (95% CI 5.0–9.0)

Median OS 22.4 months (95% CI 21.7–NE)

Horwitz et al.85

II

PTCL

35

64 (33–83)

ORR 41% (95% CI 24.6–59.3)

CR 24%

PR 18%

Median DOR 7.6 months (95% CI 1.3–14+)

Median PFS 2.6 months

Median PFS in AITL cohort 6.7 months

Median PFS in PTCL-NOS cohort 1.6 months

Median OS not reported

Duvic et al.86

II

CTCL (MF, pcALCL, LyP)

48 (28 with MF, 9 with LyP, 2 with pcALCL)

59.5 (31–77)

ORR 73%

ORR 54% in MF group

ORR 100% in other subgroups

CR 2/28, PR 13/28 in MF subgroup

Not reported

PFS 1.1 years (95% CI 0.9–1.4)

Kim et al.27

II

CTCL (MF and SS)

32 (30 evaluable for efficacy)

62 (20–87)

ORR in 21/30 (70%, 90% CI 53–83)

CR in 1/30

PR in 20/30SD in 4/30

Not reported

Median PFS not reached at 12 months

Median EFS >6 months

61% event free at 6 months

28% event free at 12 months

Jacobsen et al.21

II

B-cell lymphoma

68 (48 with DLBCL, 19 other B-cell lymphomas)

62 (17–85) in DLBCL cohort

36 (16–68) in other lymphoma cohort

ORR 44% in DLBCL cohort (95% CI 29.5–58.8)

CR 17%

PR 27%

ORR 26% in other lymphoma cohort (95% CI 9.1–51.2)

CR 16%

PR 11%

Median DOR in DLBCL cohort 5.6 months (0–22.7+ months)

Median PFS in DLBCL cohort 4 months (0.6–24 months)

Prince et al.87

III

Comparison of BV with physician’s choice of either bexarotene or methotrexate

CTCL

128 (97 with MF, 31 with pcALCL) with 64 in BV group, 64 in PC group

62 (22-83) in BV group

58 (22–83) in PC group

ORR4 56.3% (BV group) versus 12.5% (PC group), with P<0.0001

ORR 67% in BV group

CR 16%

ORR 20% in PC group

CR 2%

Not reported

Median PFS 16.7 months (BV group) versus 3.5 months (PC group), with P<0.0001

Bartlett et al.88

II

DLBCL

52

 

ORR 31%

CR 12%

 

Median PFS 1.4 months (0.4–15.6)

Median OS 7.5 months (0.7–18.6+)

  1. Abbreviations: AITL, angioimmunoblastic T-cell lymphoma; CI, confidence interval; CR, complete response; CTCL, cutaneous T-cell lymphoma; DLBCL, diffuse large B-cell lymphoma; DOR, duration of objective response; EFS, event-free survival; HL, Hodgkin lymphoma; LyP, lymphomatoid papulosis; MF, mycosis fungoides; NE, not evaluable; ORR, objective response rate; ORR4, objective response rate at 4 months; OS, overall survival; PC, physician’s choice; pcALCL, primary cutaneous anaplastic large cell lymphoma; PFS, progression-free survival; PR, partial response; PTCL, peripheral T-cell lymphoma; PTCL-NOS, peripheral T-cell lymphoma, not otherwise specified; sALCL, systemic anaplastic large cell lymphoma; SD, stable disease; SS, Sezary syndrome.
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