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Letters to the Editor
Slight accumulation was observed in patients receiving 40 mg. Anti-drug antibodies were detected in one of 25 patients with R/R AML after the first infusion in cycle 1; however, this patient had tested positive prior to treat- ment commencement.
Baseline absolute counts of CD33+ blasts in peripheral
blood and bone marrow were highly variable, ranging from 15% to 95% and 28% to 95% of total blasts, respectively. Overall, total blood blasts remained unchanged following treatment with BI 836858. However, pharmacodynamic analyses showed decreased levels of CD33+ blasts in blood after adminis-
Table 1. Baseline demographics and characteristics of patients with relapsed/refractory acute myeloid leukemia treated with BI 836858. BI 836858 dose
Characteristics
Male
Race White
Age, years Median (range) <65
≥65
ECOG PS 0
1 2
Type of AML
De novo
Secondary
Blasts in bone marrow Median, % (range)
Bone marrow blasts category <30%
≥30% Missing
10 mg N=12
6 (50)
63.5 (36-77) 6 (50)
6 (50)
4 (33) 8 (67) 0
7 (58) 5 (42)
18.0 (4.0-96.0)
7 (58) 4 (33) 1 (8)
20 mg N=8
6 (75)
6 (75)
2 (25)
62.0 (45-67) 4 (50)
4 (50)
1 (13) 5 (63) 2 (25)
3 (38) 5 (63)
56.0 (0-90.0)
2 (25) 6 (75) 0
40 mg N=7
3 (43)
70.0 (63-81) 1 (14)
6 (86)
1 (14) 3 (43) 3 (43)
5 (71) 2 (29)
50.0 (1.0-92.0)
2 (29) 5 (71) 0
All patients N=27
15 (56)
24 (89) 2 (7) Multiple* 0 0 1(14) 1(4)
Black/African American
12 (100) 0
6 (86) 0
67.0 (36-81) 11 (41) 16 (59)
6 (22) 16 (59) 5 (19)
15 (56) 12 (44)
41.5 (0-96.0)
11 (41) 15 (56) 1 (4)
Previous systemic anti-leukemia therapies
Median, n (range)
≥1 line of iHD
≥1lineofpLD 3(25) 3(38) 3(43) 9(33) ≥1lineofASCT 4(33) 2(25) 1(14) 7(26) ≥1lineofother 2(17) 1(13) 0 3(11)
*American Indian/Alaskan native and White. Data are n (%), unless otherwise stated. iHD: intensive high dose; pLD: palliative low dose; ECOG PS: Eastern Cooperative Oncology Group performance status; R/R AML: relapsed or refractory acute myeloid leukemia; ASCT: allogeneic stem cell transplantation.
Table 2. All-cause adverse events by MedDRA preferred terms and highest CTCAE grade in patients with relapsed or refractory acute myeloid leukemia treated with BI 836858 during the on-treatment period.
2.0 (1-7) 10 (83)
3.5 (1-9) 8 (100)
2.0 (1-5) 7 (100)
3.0 (1-9) 25 (93)
AE, n (%)
Total with AE
Febrile neutropenia
Nausea
Infusion-related reactions
Anemia 10(37)
All grades
Grade 1/2 Grade 3 Grade 4
2 (7) 11 (41) 6 (22)
1(4) 11(41) 0 12(44) 0 0 8 (30) 3(11) 0
1(4) 8(30) 1(4)
Grade 5
8 (30) 0
0
0
0
0
0
0
0
0
0
27 (100) 12 (44) 12 (44) 11 (41)
Dyspnea
Platelet count decreased
Constipation
White blood cell count decreased
Hypokalemia
Fatigue
Sepsis
Atrial fibrillation
9(33)
8 (30)
7 (26)
7 (26)
7 (26)
6(22)
4(15)
3 (11)
8(30) 0
7 (26) 1 (4) 6 (22) 5(19) 0
1(4) 0
0
1 (4) 1 (4) 1(4) 1(4)
0
8 (30) 0
5 (19) 0
0
2(7) 1(4) 0 3(11) 0 0
Adverse events (AE) shown are those occurring in >20% of patients for all grades and grade 1/2, >10% for grade 3 and all grade 4. CTCAE: common terminology criteria for adverse events; R/R AML: relapsed or refractory acute myeloid leukemia. Medical dictionary for drug regulatory activities (MedDRA) version used for reporting: 21.0.
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