Table 1.

Baseline patient and disease characteristics by DS.

IvosidenibEnasidenib
TotalDSNo DSTotalDSNo DS
(n = 179)(n = 34)(n = 145)(n = 214)(n = 41)(n = 173)
Age
 Median (range)67 (18–87)68 (45–87)67 (18–86)68 (19–100)67 (42–89)68 (19–100)
 <65 y, n (%)67 (37)13 (38)54 (37)85 (40)18 (44)67 (39)
 ≥65 y, n (%)112 (63)21 (62)91 (63)129 (60)23 (56)106 (61)
Sex, n (%)
 Female89 (50)19 (56)70 (48)105 (49)19 (46)86 (50)
 Male90 (50)15 (44)75 (52)109 (51)22 (54)87 (50)
Race, n (%)
 White112 (63)20 (59)92 (63)164 (77)29 (71)135 (78)
 Black10 (6)3 (9)7 (5)12 (6)2 (5)10 (6)
 Asian6 (3)0 (0)6 (4)1 (<1)1 (2)0 (0)
 Other9 (5)3 (9)6 (4)3 (1)1 (2)2 (1)
 Not provided42 (23)8 (24)34 (23)34 (16)8 (20)26 (15)
ECOG PS, n (%)
 0–1135 (75)23 (68)112 (77)181 (85)34 (83)147 (85)
 ≥244 (25)11 (32)33 (23)32 (15)7 (17)25 (14)
 Missing0 (0)0 (0)0 (0)1 (<1)0 (0)1 (1)
Type of AML, n (%)
De novo120 (67)17 (50)103 (71)163 (76)30 (73)133 (77)
 Secondary59 (33)17 (50)42 (29)51 (24)11 (27)40 (23)
Cytogenetics,a n (%)
 Intermediate105 (59)18 (53)87 (60)108 (50)18 (44)90 (52)
 Poor50 (28)11 (32)39 (27)55 (26)13 (32)42 (24)
 Unknown/missing24 (14)5 (15)19 (13)51 (24)10 (24)41 (23)
IDH mutation, n (%)
IDH1 R132C102 (57)19 (56)83 (57)
IDH1 R132H42 (23)12 (35)30 (21)
IDH1 R132G/L/S29 (16)3 (9)26 (18)
 NA/ND6 (4)0 (0)6 (4)3 (1)0 (0)3 (2)
IDH2 R140161 (75)33 (80)128 (74)
IDH2 R17250 (23)8 (20)42 (24)
Prior regimens, n (%)
 1 prior regimen75 (42)12 (35)63 (43)98 (46)23 (56)75 (43)
 ≥2 prior regimens102 (57)21 (62)81 (56)116 (54)18 (44)98 (57)
 Missing2 (1)1 (3)1 (1)0 (0)0 (0)0 (0)
Prior HSCT, n (%)
 Yes43 (24)11 (32)32 (22)29 (14)7 (17)22 (13)
WBC count (Gi/L)
 Median (range)1.9 (0.1–47.5)3.6 (0.3–32.5)1.6 (0.1–47.5)2.3 (0.2–93.8)2.8 (0.4–93.8)2.3 (0.2–88.2)
 <10, n (%)145 (81)27 (79)118 (81)164 (77)28 (68)136 (79)
 ≥10, n (%)34 (19)7 (21)27 (19)49 (23)13 (32)36 (21)
 Missing, n (%)0 (0)0 (0)0 (0)1 (<1)0 (0)1 (1)
ANC (Gi/L)
 Median (range)0.19 (0–10.9)0.20 (0–4.5)0.15 (0–10.9)0.39 (0–38)0.40 (0–38)0.39 (0–18)
 ANC < 500, n (%)124 (69)23 (68)101 (70)119 (56)23 (56)96 (55)
 ANC ≥ 500, n (%)48 (27)11 (32)37 (26)91 (43)17 (41)74 (43)
 Missing, n (%)7 (4)0 (0)7 (5)4 (2)1 (2)3 (2)
Peripheral blast (%)
 Median (range)24.5 (0–97)34 (0–96.5)19.5 (0–97)14.5 (0–98)43.5 (0–96)13 (0–98)
 <20%, n (%)75 (42)9 (26)66 (46)101 (47)13 (32)88 (51)
 ≥20%, n (%)89 (50)23 (68)66 (46)81 (38)20 (49)61 (35)
 Missing, n (%)15 (8)2 (6)13 (9)32 (15)8 (20)24 (14)
BM blast (%)
 Median (range)48 (0–98)59 (0–97)42 (4–98)48 (0–98)63 (1–98)42 (0–96)
 <50%, n (%)90 (50)12 (35)78 (54)104 (49)13 (32)91 (53)
 ≥50%, n (%)89 (50)22 (65)67 (46)100 (47)28 (68)72 (42)
 Missing, n (%)0 (0)0 (0)0 (0)10 (5)0 (0)10 (6)
CrCl (mL/min)
 Median (range)86 (21–253)80 (41–253)86 (21–231)83 (29–237)79 (37–197)85 (29–237)
 <60 mL/min, n (%)33 (18)6 (18)27 (19)44 (21)9 (22)35 (20)
 ≥60 mL/min, n (%)143 (80)28 (82)115 (79)169 (79)32 (78)137 (79)
 Missing, n (%)3 (2)0 (0)3 (2)1 (<1)0 (0)1 (1)
LDH (U/L)
 Median (range)248 (63–3059)288 (127–1957)246 (63–3059)258 (57–5938)275 (84–1937)252 (57–5938)
 Low/normal, n (%)99 (55)14 (41)85 (59)131 (61)22 (54)109 (63)
 Elevated, n (%)80 (45)20 (59)60 (41)78 (36)17 (41)61 (35)
 Missing, n (%)0 (0)0 (0)0 (0)5 (2)2 (5)3 (2)
  • Abbreviations: BM, bone marrow; CrCl, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group performance status; NA/ND, not analyzable/not detected.

  • aCytogenetic risk was reported per investigator determination.