Patient demographics and baseline disease characteristics (ITT population, R/R cohorts, and 1L cohort)
| Characteristic . | R/R MDS . | 1L MDS . | ||
|---|---|---|---|---|
| Cohort A (n = 11) . | Cohort B (n = 14) . | All (n = 25) . | Cohort C (n = 21) . | |
| Age, y | 71 (63-87) | 76 (66-89) | 75 (63-89) | 72 (50-81) |
| Male sex | 8 (72.7) | 9 (64.3) | 17 (68.0) | 15 (71.4) |
| Bone marrow blasts, % | 5 (2-14) | 1 (1-17) | 6 (1-17) | 5 (0-15) |
| Cytogenetics | ||||
| Very good | 0 | 2 (14.3) | 2 (8.0) | 0 |
| Good | 6 (54.5) | 7 (50.0) | 13 (52.0) | 8 (38.1) |
| Intermediate | 1 (9.1) | 4 (28.6) | 5 (20.0) | 8 (38.1) |
| Poor | 1 (9.1) | 0 | 1 (4.0) | 0 |
| Very poor | 3 (27.3) | 1 (7.1) | 4 (16.0) | 5 (23.8) |
| IPSS-R at screening | ||||
| Very low | 0 | 0 | 0 | 0 |
| Low | 0 | 1 (7.1) | 1 (4.0) | 0 |
| Intermediate | 1 (9.1) | 2 (14.3) | 3 (12.0) | 9 (42.9) |
| High | 0 | 0 | 0 | 6 (28.6) |
| Very high | 0 | 0 | 0 | 6 (28.6) |
| Missing/unknown | 10 (90.9) | 11 (78.6) | 21 (84.0) | — |
| ECOG PS | ||||
| 0 | 3 (27.3) | 3 (21.4) | 6 (24.0) | 1 (4.8) |
| 1 | 8 (72.7) | 10 (71.4) | 18 (72.0) | 19 (90.5) |
| 2 | 0 | 1 (7.1) | 1 (4.0) | 1 (4.8) |
| Prior lines of therapy, n | ||||
| 1 | 6 (54.5) | 8 (57.1) | 14 (56.0) | 0 |
| 2 | 3 (27.3) | 1 (7.1) | 4 (16.0) | 0 |
| ≥3 | 2 (18.2) | 5 (35.7) | 7 (28.0) | 1 (4.8) |
| Prior ASCT | 0 | 0 | 0 | 1 (4.8) |
| Characteristic . | R/R MDS . | 1L MDS . | ||
|---|---|---|---|---|
| Cohort A (n = 11) . | Cohort B (n = 14) . | All (n = 25) . | Cohort C (n = 21) . | |
| Age, y | 71 (63-87) | 76 (66-89) | 75 (63-89) | 72 (50-81) |
| Male sex | 8 (72.7) | 9 (64.3) | 17 (68.0) | 15 (71.4) |
| Bone marrow blasts, % | 5 (2-14) | 1 (1-17) | 6 (1-17) | 5 (0-15) |
| Cytogenetics | ||||
| Very good | 0 | 2 (14.3) | 2 (8.0) | 0 |
| Good | 6 (54.5) | 7 (50.0) | 13 (52.0) | 8 (38.1) |
| Intermediate | 1 (9.1) | 4 (28.6) | 5 (20.0) | 8 (38.1) |
| Poor | 1 (9.1) | 0 | 1 (4.0) | 0 |
| Very poor | 3 (27.3) | 1 (7.1) | 4 (16.0) | 5 (23.8) |
| IPSS-R at screening | ||||
| Very low | 0 | 0 | 0 | 0 |
| Low | 0 | 1 (7.1) | 1 (4.0) | 0 |
| Intermediate | 1 (9.1) | 2 (14.3) | 3 (12.0) | 9 (42.9) |
| High | 0 | 0 | 0 | 6 (28.6) |
| Very high | 0 | 0 | 0 | 6 (28.6) |
| Missing/unknown | 10 (90.9) | 11 (78.6) | 21 (84.0) | — |
| ECOG PS | ||||
| 0 | 3 (27.3) | 3 (21.4) | 6 (24.0) | 1 (4.8) |
| 1 | 8 (72.7) | 10 (71.4) | 18 (72.0) | 19 (90.5) |
| 2 | 0 | 1 (7.1) | 1 (4.0) | 1 (4.8) |
| Prior lines of therapy, n | ||||
| 1 | 6 (54.5) | 8 (57.1) | 14 (56.0) | 0 |
| 2 | 3 (27.3) | 1 (7.1) | 4 (16.0) | 0 |
| ≥3 | 2 (18.2) | 5 (35.7) | 7 (28.0) | 1 (4.8) |
| Prior ASCT | 0 | 0 | 0 | 1 (4.8) |
Data are presented as n (%) or median (range).
1L, frontline; ASCT, autologous stem cell transplantation; ECOG PS, Eastern Cooperative Oncology Group performance status; ITT, intention to treat.