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Table 1 Early clinical trials evaluating inotuzumab ozogamicin monotherapy in adults with relapsed/refractory B-cell ALL

From: Inotuzumab ozogamicin for the treatment of adult acute lymphoblastic leukemia: past progress, current research and future directions

Study

N

Age, median [range]

INO dosing

CR/CRi Rate

HSCT Rate

Median OS

VOD/SOS rate

Kantarjian H et al. 2013 [11]

(Phase II)

90

39.5 [4–84]

• Patients #1–49: 1.3–1.8 mg/m2 once per cycle

• Patients #50–90: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycle

58%

40%

6.2 months

17%a

Deangelo DJ et al. 2017 [12]

(Phase I/II)

72

45 [20–79]

• Induction: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycleb

• Once in CR/CRi: 0.8 mg/m2 on D1, 0.4 mg/m2 on D8 and D15 each cycle

68%

33%

7.4 months

6%

Kantarjian H et al. 2016 [1]

(Phase III)

164c

47 [18–78]

• Induction: 0.8 mg/m2 on D1, 0.5 mg/m2 on D8 and D15 each cycle

• Once in CR/CRi: 0.5 mg/m2 on D1, D8 and D15 each cycle

80.7%

41%

7.7 months

11%

  1. Abbreviations: INO, inotuzumab ozogamicin; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; HSCT, hematopoietic stem cell transplant; OS, overall survival ; VOD/SOS, veno-occlusive disease / sinusoidal obstruction syndrome
  2. a VOD/SOS rate only reported in transplanted patients
  3. b Phase II doses are shown in the table. Phase I of the study evaluated induction INO doses of 1.2–1.8 mg/m2 given in divided dosing
  4. c Data refer only to patients randomized to the INO arm