Demographics and baseline characteristics of patients with HMA-naïve CMML in part 2B
| Characteristic . | Patients with CMML (N = 21)∗ . |
|---|---|
| Median age (range), y | 71 (54-82) |
| Sex, % (n) | |
| Male | 66.7 (14) |
| Female | 33.3 (7) |
| Ethnicity, % (n) | |
| Hispanic or Latino | 14.3 (3) |
| Not Hispanic or Latino | 85.7 (18) |
| Race, % (n) | |
| White | 71.4 (15) |
| Asian | 19.0 (4) |
| Unknown | 4.76 (1) |
| Chose not to disclose | 4.76 (1) |
| ECOG performance status, % (n) | |
| 0 | 14.3 (3) |
| 1 | 66.7 (14) |
| 2 | 19.0 (4) |
| No. of prior lines of therapy, % (n) | |
| 0 | 81.0 (17) |
| 1 | 19.0 (4) |
| Prior treatment, % (n) | 19.0 (4)† |
| Prior allo-HCT, % (n) | 0 |
| Dysplastic/proliferative, % (n) | 42.9 (9) /57.1 (12) |
| CMML-1/CMML-2, % (n) | 81 (17) / 19 (4) |
| Patients with blasts >5%, % (n) | 47.6 (10) |
| Splenomegaly, % (n) | 9.5 (2) |
| Transfusion dependence, % (n) | 38.1 (8) |
| MPN-SAF TSS >20, % (n) | 38.1 (8) |
| MPN-SAF TSS >15, % (n) | 47.6 (10) |
| >50% LILRB4-positive blasts and >4500 copies per cell, % (n/no. of patient with data available) | 31.6 (6/19) |
| High risk by CPSS-Mol (score ≥4), % (n/no. of patient with data available) | 45 (9/20) |
| Abnormal cytogenetics, % (n) | 19.1 (4) |
| Reticulin fibrosis grade ≥1, % (n/no. of patient with data available) | 10 (2/20) |
| Abnormal BM cellularity, % (n) | 90.5 (19) |
| Most frequent gene mutations, % (n) | |
| ASXL1 | 71.4 (15) |
| TET2 | 47.6 (10) |
| RUNX1 | 23.8 (5) |
| SRSF2 | 23.8 (5) |
| Any of KRAS, NRAS, CBL, or PTPN11 | 47.6 (10) |
| Characteristic . | Patients with CMML (N = 21)∗ . |
|---|---|
| Median age (range), y | 71 (54-82) |
| Sex, % (n) | |
| Male | 66.7 (14) |
| Female | 33.3 (7) |
| Ethnicity, % (n) | |
| Hispanic or Latino | 14.3 (3) |
| Not Hispanic or Latino | 85.7 (18) |
| Race, % (n) | |
| White | 71.4 (15) |
| Asian | 19.0 (4) |
| Unknown | 4.76 (1) |
| Chose not to disclose | 4.76 (1) |
| ECOG performance status, % (n) | |
| 0 | 14.3 (3) |
| 1 | 66.7 (14) |
| 2 | 19.0 (4) |
| No. of prior lines of therapy, % (n) | |
| 0 | 81.0 (17) |
| 1 | 19.0 (4) |
| Prior treatment, % (n) | 19.0 (4)† |
| Prior allo-HCT, % (n) | 0 |
| Dysplastic/proliferative, % (n) | 42.9 (9) /57.1 (12) |
| CMML-1/CMML-2, % (n) | 81 (17) / 19 (4) |
| Patients with blasts >5%, % (n) | 47.6 (10) |
| Splenomegaly, % (n) | 9.5 (2) |
| Transfusion dependence, % (n) | 38.1 (8) |
| MPN-SAF TSS >20, % (n) | 38.1 (8) |
| MPN-SAF TSS >15, % (n) | 47.6 (10) |
| >50% LILRB4-positive blasts and >4500 copies per cell, % (n/no. of patient with data available) | 31.6 (6/19) |
| High risk by CPSS-Mol (score ≥4), % (n/no. of patient with data available) | 45 (9/20) |
| Abnormal cytogenetics, % (n) | 19.1 (4) |
| Reticulin fibrosis grade ≥1, % (n/no. of patient with data available) | 10 (2/20) |
| Abnormal BM cellularity, % (n) | 90.5 (19) |
| Most frequent gene mutations, % (n) | |
| ASXL1 | 71.4 (15) |
| TET2 | 47.6 (10) |
| RUNX1 | 23.8 (5) |
| SRSF2 | 23.8 (5) |
| Any of KRAS, NRAS, CBL, or PTPN11 | 47.6 (10) |
Included were 21 patients from the safety analysis set.
ECOG, Eastern Cooperative Oncology Group; MPN-SAF TSS, MPN symptom assessment form total symptom score.
Part 2B enrolled 21 patients with HMA-naïve CMML. If a different denominator applies to a specific characteristic, it will be indicated in the relevant characteristic.
Three were treated with hydroxyurea, and 1 was treated with fedratinib.