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Table 2 Response rates to olutasidenib and azacitidine combination treatment

From: Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial

Response rates

R/R AML

(N = 67)

R/R AML excluding prior olutasidenib

(N = 51)

CR rate

  

Response rate, n (%) [95% CI]

18 (27%)

[95% CI 16.8 - 39.1]

16 (31%)

[95% CI 19.1 - 45.9]

Time to CR, median months (range)

2.95 (1-7.6)

3.3 (1-7.6)

Duration of CR, median months [95% CI]

20.3

[95% CI 3.7 - NR]a

20.3

(95% CI 5.6 - NR)c

CR/CRh rate

  

Response rate, n (%) [95% CI]

21 (31%)

[95% CI 20.6 - 43.8]

19 (37%)

[95% CI 24.1 - 51.9]

Time to CR/CRh, median months (range)

3 (1-9.5)

3.6 (1-9.5)

Duration of CR/CRh, median months [95% CI]

14.7 [95% CI 4.6 - NR]a

14.7 [95% CI 4.6 - NR]c

Overall response rate

  

Response rate, n (%) [95% CI]

34 (51%)

[95% CI 38.2–63.2]

30 (59%)

[95% CI 44.2 - 72.4]

Time to first OR, median months (range)

1.95 (0.9-7.6)

1.9 (0.9-7.6)

Duration of OR, median months [95% CI]

6.5 [95% CI 3.7 - 21.2]b

8 [95% CI 4.5 - 21.2]d

Best overall response, n (%)

  

CR/CRh/CRi

26 (39)

23 (45)

CR

18 (27)

16 (31)

CRh

3 (4)

3 (6)

CRi

5 (7)

4 (8)

MLFS

4 (6)

4 (8)

PR

4 (6)

3 (6)

Stable disease

24 (36)e

15 (29)e

Progressive disease

2 (3)

2 (4)

Not evaluable/not done

7 (10)

4 (8)

  1. NR not reached, CR complete remission, CRh CR with partial hematologic recovery, CRi CR with incomplete recovery, MLFS morphologic leukemia-free state, PR partial remission, SD stable disease (failure to achieve at least a PR but not meeting criteria for progressive disease)
  2. a11 patients censored
  3. b14 patients censored
  4. c10 patients censored
  5. d13 patients censored
  6. eIncludes 2 patients considered to have clinical benefit by the treating physician, defined as having SD for a period of ≥ 8 weeks