Table 1.
Patient demographics and baseline disease characteristics (ITT Population)
| Demographics/Characteristics (N=45) | Value |
|---|---|
| Median age, years (range) | 72 (47 – 84) |
|
| |
| Sex, n (%) | |
| Male | 39 (87) |
| Female | 6 (13) |
|
| |
| ECOG performance status, n (%) | |
| 0 | 11 (24) |
| 1 | 28 (62) |
| 2 | 6 (13) |
|
| |
| Median time since first diagnosis, years (range) | 3.3 (0.2 – 16.3) |
|
| |
| IPSS risk score at screening, n (%) | |
| Low | 12 (27) |
| Intermediate-1 | 33 (73) |
|
| |
| WHO classification at screening, n (%) | |
| RA/RARS | 11 (24) |
| RCMD/RCMD-RS | 18 (40) |
| RAEB-1 | 7 (16) |
| RAEB-2 | 2 (4) |
| MDS-U | 6 (13) |
| MDS with isolated del(5q) | 1 (2) |
|
| |
| % Blasts (bone marrow aspirate), n (%) | |
| < 5 | 40 (89) |
| ≥ 5 | 4 (9) |
| >10 | 0 (0) |
| No data | 1 (2) |
|
| |
| Number of cytopenias, n (%) | |
| 0 | 1 (2) |
| 1 | 19 (42) |
| 2 | 12 (27) |
| 3 | 13 (29) |
|
| |
| Hemoglobin < 11 g/dL1, n (%) | 41 (91) |
|
| |
| ANC2, n (%) | |
| 0.5 – < 1.0 × 109/L | 7 (16) |
| < 0.5 × 109/L | 9 (20) |
|
| |
| Platelets3 | |
| 50 – < 100 × 109/L | 22) |
| < 50 × 109/L | 15 (33) |
|
| |
| Karyotype4, n (%) | |
| Good | |
| Normal | 29 (64.4) |
| -Y | 4 (8.9) |
| del (20q) | 2 (4.4) |
| del (5q) | 1 (2.2) |
| Intermediate | 8 (17.8) |
| Complex | 1 (2.2) |
|
| |
| Transfusions within 8 weeks prior to first day of dosing in Cycle 1, n (%) | |
| Any RBC transfusion | 38 (84) |
| RBC transfusion dependent5 | 25 (56) |
| Any platelet transfusion | 7 (16) |
|
| |
| Median number of prior therapies, n (range) | 2 (0 – 9) |
| ≥ 1 prior hypomethylating agent (HMA) 5, n (%) | 36 (80) |
| Prior lenalidomide, n (%) | 19 (42) |
| Prior erythropoiesis-stimulating agent6, n (%) | 26 (58) |
Mean hemoglobin <11 g/dL for the 56 days prior to the first dose of ARRY-614 that was not influenced by a red blood cell (RBC) transfusion in the 14 days prior to an assessment.
Mean absolute neutrophil counts for the specified ranges for the 56 days prior to the first dose of ARRY-614.
Mean platelets for the specified ranges for the 56 days prior to the first dose of ARRY-614 that was not influenced by a platelet transfusion in the 3 days prior to an assessment.
Good, Intermediate and Complex classification based on IPSS criteria.
All patients who were administered ≥ 4 units of RBCs for Hgb levels ≤9 g/dL in the 56 days prior to the first dose of ARRY-614.
Includes azacitidine and decitabine.
Includes darbepoetin alfa, erythropoietin, and epoietin alfa.