Table 1 Baseline demographic and disease characteristicsa.

From: Safety and efficacy of BAY1436032 in IDH1-mutant AML: phase I study results

 

Cohort 1: 300 mg BID

Cohort 2: 600 mg BID

Cohort 3: 1200 mg BID

Cohort 4: 1500 mg BID

Total

 

n = 7

n = 4

n = 7

n = 9

n = 27

Age [median (range), in years]

67 (37–86)

72 (51–76)

70 (42–83)

68 (27–79)

69 (27–86)

Sex, n (%)

     

 Male

4 (57)

2 (50)

3 (43)

3 (33)

12 (44)

 Female

3 (43)

2 (50)

4 (57)

6 (67)

15 (56)

AML classification, n (%)

     

 De novo AML

5 (71)

3 (75)

4 (51)

7 (78)

19 (70)

 Secondary AML

2 (29)

1 (25)

3 (43)

2 (22)

8 (30)

ECOG performance status, n (%)

     

 0

1 (14)

1 (25)

1 (14)

1 (11)

4 (15)

 1

4 (57)

2 (50)

6 (86)

7 (78)

19 (70)

 2

2 (29)

1 (25)

0

1 (11)

4 (15)

Time from initial diagnosis to 1st dose of study drug [median (range), in months]b

9 (1–32)

10 (2–19)

9 (1–25)

15 (5–44)

11 (1–44)

ELN risk classification, n (%)c

     

 Favorable

0

0

1 (14)

2 (22)

3 (11)

 Intermediate

1 (14)

1 (25)

3 (43)

2 (22)

7 (26)

 Adverse

4 (57)

2 (50)

2 (29)

5 (56)

13 (48)

 Missing

2 (29)

1 (25)

1 (14)

0

4 (15)

mIDH1 identified, n (%)d

     

 R132C

3 (43)

2 (50)

5 (71)

5 (56)

15 (56)

 R132H

3 (43)

0

0

2 (22)

5 (19)

 R132G

1 (14)

2 (50)

0

0

3 (11)

 R132L

0

0

2 (29)

0

2 (7)

 R132S

0

0

0

2 (22)

2 (7)

Number of prior systemic antileukemic lines of therapies for AML, [median (range)]

1 (0–4)

1 (1–3)

2 (0–4)

3 (1–8)

2 (0–8)

Subjects having received at least 1 prior systemic antileukemic therapy for AML, n (%)

5 (71)

4 (100)

5 (71)

9 (100)

23 (85)

Prior allogeneic transplantation

     

 No

6 (86)

4 (100)

7 (100)

7 (78)

24 (89)

 Yes

1 (14)

0

0

2 (22)

3 (11)

  1. BID twice-daily, ECOG Eastern Cooperative Oncology Group, ELN European LeukemiaNet, n number of subjects.
  2. aPercentages are calculated including missing values.
  3. bFor the calculation of time from initial diagnosis, only subjects with complete date information (year, month, day) are included.
  4. cELN classification as per 2010 recommendations [20].
  5. dInvestigator-reported mIDH1 results used for subject enrollment are shown. Retrospective evaluation of baseline leukemic samples at a central laboratory via next-generation sequencing confirmed investigator-reported results in all evaluable cases.
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