Phase 1/2 study of pacritinib, a next generation JAK2/FLT3 inhibitor, in myelofibrosis or other myeloid malignancies

Table 4 Baseline characteristics and demographics for patients enrolled in phase 2 (n = 33)^a

	Pacritinib 400 mg
	n = 33^b
Median age, years (range)	67.0 (47–83)
Male, n (%)	22 (66.7)
Median time from initial diagnosis, months (range)	31.8 (0.3–210.0)
Median prior systemic therapies, n (range)	1 (0–4)
Median time since last MF treatment^c, months (range)	1.68 (0.6-36.4)
ECOG PS, n (%)
0	6 (18.2)
1	19 (57.6)
2	8 (24.2)
JAK2 mutation^d, n (%)	27 (81.8)
Type of myelofibrosis, n (%)
Primary myelofibrosis	17 (51.5)
Post-polycythemia vera myelofibrosis	12 (36.4)
Post-essential thrombocythemia myelofibrosis	4 (12.1)
Current Lille Score, n (%)
High risk	1 (3.0)
Intermediate risk	7 (21.2)
Low risk	2 (6.1)
Missing^e	23 (69.7)
Current DIPSS risk category, n (%)
High risk	7 (21.2)
Intermediate-2 risk	9 (27.3)
Intermediate-1 risk	3 (9.1)
Indeterminate^f	14 (42.4)
Hemoglobin
Median^g, g/L (range)	90.0 (37–144)
Grade 0–2, n (%)	27 (81.8)
Grade 3, n (%)	6 (18.2)
Baseline hemoglobin level, n (%)
<10 g/L	20 (60.6)
<8 g/L	6 (18.2)
RBC-transfusion dependent^g, n (%)	6 (19.4)
Platelets
Median^g, ×10⁹/L (range)	126.0 (28–494)
Grade 0–2, n (%)	29 (87.9)
Grade 3, n (%)	4 (12.1)
Baseline platelet count, n (%)
<100 × 10⁹/L	10 (42.4)
<50 × 10⁹/L	4 (12.1)
Platelet-transfusion dependent^g, n (%)	0
Leukocytes
Median^g, ×10⁹/L (range)	8.91 (1.5–38.2)
Grade 0–2, n (%)	31 (93.9)
Grade 3, n (%)	2 (6.1)
Baseline leukocyte count >25 × 10⁹/L, n (%)	3 (9.1)

^aTwo patients enrolled in the study did not receive the study drug: one patient withdrew consent before beginning treatment and the second patient was unable to undergo magnetic resonance imaging (one of the eligibility criteria)
^b97% of patients were white
^cIn patients who had received prior treatment (n = 25)
^dAll JAK2 mutations were V617F
^eCase report forms were designed for direct entry of Lille score by sites; however, some versions of the forms were missing the field for entry of Lille score
^fUnable to calculate DIPSS risk category due to missing baseline peripheral blood blasts
^gIn the safety population (n = 31)
DIPSS Dynamic International Prognostic Scoring System, ECOG PS Eastern Cooperative Oncology Group Performance Status

ISSN: 1756-8722