Response rate summary for patients with R/R AML or newly diagnosed AML receiving uproleselan in combination with chemotherapy
Outcome . | Patients, n/N (%) . | ||
---|---|---|---|
R/R (n = 66) . | R/Ruproleselan at 10 mg/kg (n = 54) . | Newly diagnosed patients age ≥60 y (n = 25) . | |
ORR (CR/CRi) | 26 (39) | 22 (41) | 18 (72) |
Primary refractory | 8/22 (36) | 5/17 (29) | — |
1 induction regimen | 6/17 (35) | 4/13 (31) | — |
≥2 induction regimens | 2/5 (40) | 1/4 (25) | — |
Relapsed | 18/44 (41) | 17/37 (46) | — |
1 induction regimen | 12/27 (44) | 12/23 (52) | — |
≥2 induction regimens | 6/17 (35) | 5/14 (36) | — |
Duration of remission, mo | |||
<6 | 4/22 (18) | 4/18 (22) | — |
≥6 | 14/22 (64) | 13/19 (78) | — |
<12 | 8/32 (25) | 7/25 (28) | — |
≥12 | 10/12 (83) | 10/12 (83) | — |
Prior HSCT | 5/12 (42) | 5/9 (56) | — |
De novo (n = 12) | — | — | 9 (75) |
Secondary (n = 13) | — | — | 9 (69) |
CR | 22 (33) | 19 (35) | 13 (52) |
CR/CRi/MLFS/PR | 32 (48) | 27 (50) | 20 (80) |
MRD* | (n = 16) | (n = 13) | (n = 9) |
Positive | 5 (31) | 4 (31) | 4 (44) |
Negative† | 11 (69) | 9 (69) | 5 (56) |
Proceeded to HSCT | 18 (27) | 17 (31) | 13 (52) |
All-cause mortality, d | |||
30 | 1 (2) | 1 (2) | 2 (8) |
60 | 6 (9) | 5 (9) | 3 (12) |
Outcome . | Patients, n/N (%) . | ||
---|---|---|---|
R/R (n = 66) . | R/Ruproleselan at 10 mg/kg (n = 54) . | Newly diagnosed patients age ≥60 y (n = 25) . | |
ORR (CR/CRi) | 26 (39) | 22 (41) | 18 (72) |
Primary refractory | 8/22 (36) | 5/17 (29) | — |
1 induction regimen | 6/17 (35) | 4/13 (31) | — |
≥2 induction regimens | 2/5 (40) | 1/4 (25) | — |
Relapsed | 18/44 (41) | 17/37 (46) | — |
1 induction regimen | 12/27 (44) | 12/23 (52) | — |
≥2 induction regimens | 6/17 (35) | 5/14 (36) | — |
Duration of remission, mo | |||
<6 | 4/22 (18) | 4/18 (22) | — |
≥6 | 14/22 (64) | 13/19 (78) | — |
<12 | 8/32 (25) | 7/25 (28) | — |
≥12 | 10/12 (83) | 10/12 (83) | — |
Prior HSCT | 5/12 (42) | 5/9 (56) | — |
De novo (n = 12) | — | — | 9 (75) |
Secondary (n = 13) | — | — | 9 (69) |
CR | 22 (33) | 19 (35) | 13 (52) |
CR/CRi/MLFS/PR | 32 (48) | 27 (50) | 20 (80) |
MRD* | (n = 16) | (n = 13) | (n = 9) |
Positive | 5 (31) | 4 (31) | 4 (44) |
Negative† | 11 (69) | 9 (69) | 5 (56) |
Proceeded to HSCT | 18 (27) | 17 (31) | 13 (52) |
All-cause mortality, d | |||
30 | 1 (2) | 1 (2) | 2 (8) |
60 | 6 (9) | 5 (9) | 3 (12) |
CR, complete response; CRi, complete response with incomplete blood count recovery; d, days; HSCT, hematopoietic stem cell transplantation; MLFS, morphologic leukemia-free state; ORR, overall response rate; PR, partial response.
Evaluable patients.
MRD− bone marrow defined as ≤10−3 leukemic cells at end of induction by local assessment using multicolor flow cytometry, reverse transcription polymerase chain reaction, or next-generation sequencing.