Table 1.
Clinical and Demographic Patient Characteristics
| Characteristic | TG101348 Starting Dose (mg/d) |
MTD Cohort (n = 40) |
All Doses (n = 59) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 30 (n = 4) | 60 (n = 3) | 120 (n = 3) | 240 (n = 3) | 360 (n = 3) | 520 (n = 3) | 680 (n = 34) | 800 (n = 6) | No. | % | No. | % | |
| Age, years | 63.5 | 64.0 | 63.0 | 68.0 | 66.0 | 57.0 | 63.5 | 69.0 | ||||
| Range | 55-76 | 56-66 | 53-71 | 55-79 | 61-71 | 50-66 | 43-83 | 50-85 | 43-85 | 43-85 | ||
| Mean | 65.1 | 64.5 | ||||||||||
| SD | 10.47 | 9.70 | ||||||||||
| Sex | ||||||||||||
| Male | 2 | 3 | 1 | 2 | 2 | 2 | 18 | 4 | 22 | 55.0 | 34 | 57.6 |
| Female | 2 | 0 | 2 | 1 | 1 | 1 | 16 | 2 | 18 | 45.0 | 25 | 42.4 |
| Ethnicity | ||||||||||||
| White | 3 | 2 | 3 | 3 | 3 | 2 | 29 | 6 | 35 | 87.5 | 51 | 86.4 |
| African American | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2.5 | 1 | 1.7 |
| Asian | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 3 | 7.5 | 5 | 8.5 |
| Other | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 2.5 | 2 | 3.4 |
| Diagnosis | ||||||||||||
| PMF | 3 | 2 | 1 | 3 | 2 | 2 | 27 | 4 | 31 | 77.5 | 44 | 74.6 |
| Post-PV MF | 1 | 1 | 2 | 0 | 1 | 1 | 6 | 0 | 6 | 15.0 | 12 | 20.3 |
| Post-ET MF | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 7.5 | 3 | 5.1 |
| Mayo PSS risk category | ||||||||||||
| High | 0 | 0 | 1 | 2 | 0 | 3 | 14 | 6 | 20 | 50 | 26 | 44.1 |
| Not high* | 4 | 3 | 2 | 1 | 3 | 0 | 20 | 0 | 20 | 50.0 | 33 | 55.9 |
| JAK2V617F positive | 3 | 3 | 3 | 2 | 3 | 2 | 29 | 6 | 35 | 87.5 | 51 | 86.4 |
| Transfusion dependent | 1 | 1 | 0 | 1 | 0 | 2 | 13 | 3 | 16 | 40.0 | 21 | 35.6 |
| Spleen size > 10 cm | 3 | 3 | 3 | 2 | 3 | 2 | 28 | 5 | 33 | 82.5 | 49 | 83.1 |
Abbreviations: MTD, maximum-tolerated dose; SD, standard deviation; PMF, primary myelofibrosis; PV, polycythemia vera; MF, myelofibrosis; ET, essential thrombocythemia; PSS, prognostic scoring system; JAK, Janus kinase.
*
Equivalent to symptomatic/treatment refractory intermediate-risk disease.