Table .
Clinical trial data for JAK inhibitors evaluated in patients with MF previously treated with ruxolitinib [34–37]
| Study | N | Treatment arm(s) | Control arm | Median follow-up (median study drug exposure) | Reported study drug discontinuation rate (%) | Dose modifications* | Spleen volume response† | MFSAF symptom response |
|---|---|---|---|---|---|---|---|---|
| JAKARTA2 | 97 | FEDR 400 mg QD | N/A | 6 months (24 weeks) | 35‡ |
Interruption (≥ 7 days), 26% Dose reduction, 39% |
55% (per protocol analysis) 31% (updated ITT analysis) | 26% (per protocol analysis) 27% (updated ITT analysis) |
| PERSIST-2 | 211 | PAC 400 mg QD | BAT, including RUX (45%) | NR (24 weeks) | 40‡ | 20% | 15% (P = 0.02 vs. BAT) | 17% (P = 0.7 vs. BAT) |
| PAC 200 mg BID | 29‡ | 12% | 22% (P = 0.001 vs. BAT) | 32% (P = 0.01 vs. BAT) | ||||
| SIMPLIFY-2 | 104 | MOME 200 mg QD | BAT, including RUX (89%) | 168 days (19.5 weeks) | 34 | 16% | 7% (P = 0.9 vs. BAT) | 26% (P = 0.0006 vs. BAT) |
BAT best available therapy, BID twice daily, FEDR fedratinib, ITT intention-to-treat, MFSAF Myelofibrosis Symptom Assessment Form, MOME momelotinib, N/A not applicable, NR not reported, PAC pacritinib, QD once daily, RUX ruxolitinib
*Includes dose reductions and/or treatment interruptions
†Proportion of patients who achieved a ≥ 35% reduction in spleen volume from baseline at week 24
‡Excluding discontinuations due to study holds