Table 3.

Hematologic toxicity: neutropenia (safety population, Q3W N = 28, Q1W N = 27)

Number of patients during cycle 1
NeutropeniaFebrile neutropenia
ArmDose levelMedian nadir ANC (range)a cells/μLGrade I–IIGrade IIIGrade IVGrade III–V + Fever
Q3W3.5 mg/m2(N = 1)3,410 (3,410–3,410)0000
7 mg/m2 (N = 1)5,110 (5,110–5,110)0000
15 mg/m2 (N = 2)4,425 (4,160–4,690)0000
30 mg/m2 (N = 3)4,510 (3,900–5,848)0000
60 mg/m2 (N = 14)1,419 (100–10,800)025b0
75 mg/m2 (N = 7)264 (0–2,100)105b1
Q1W15 mg/m2 (N = 3)8,460 (1,850–10,090)1000
25 mg/m2 (N = 3)3,200 (2,600–6,500)0000
30 mg/m2 (N = 6)2,150 (1,300–4,200)1000
35 mg/m2 (N = 4)4,000 (2,200–9,670)0000
40 mg/m2 (N = 7)4,700 (2,620–7,300)0000
45 mg/m2 (N = 4)1,165 (3–2,600)101b1
  • Abbreviations: ANC, absolute neutrophil count.

  • aValues represent the median nadir ANC (range) for cycle 1.

  • bAt the Q3W 60 mg/m2 dose level, two of the five patients who experienced grade IV neutropenia also had grade IV neutropenia lasting ≥5 days. At the Q3W 75 mg/m2 dose level, two of the five patients who experienced grade IV neutropenia also had grade IV neutropenia lasting ≥5 days. At the Q1W 45 mg/m2 dose level, the one patient who experienced grade IV neutropenia also had grade IV neutropenia lasting ≥5 days.