Comparison of JAKARTA (frontline) and JAKARTA-2 (second-line) trials
| . | JAKARTA1 (frontline)23 . | JAKARTA2 (second line)24 . |
|---|---|---|
| Design | Phase 3/randomized PB controlled | Single arm |
| Dosing/arms | Placebo FEDR 400 mg FEDR 500 mg | FEDR 400 mg |
| Inclusion | Disease: primary, post-ET/PV MF Risk: DIPSS INT-2, high risk Prior RX: JAK-inhibitor naive | Disease: primary, post-ET/PV MF Risk: DIPSS INT-1 (symptomatic), INT-2, high risk Prior RX: ruxolitinib intolerant/refractory |
| Primary end point | >35% SVR | >35% SVR |
| Key secondary end point | ≥50% reduction in MFSAF-TSS | ≥50% reduction in MFSAF-TSS |
| Enrollment | N = 289 | N = 97 |
| Initial published response rates | ||
| Spleen volume response (>35% volume reduction) | FEDR 400 mg (36%) FEDR 500 mg (40%) Placebo (1%) | FEDR 400 mg (55% of 83 evaluable) |
| MFSAF-TSS (>50% reduction) | FEDR 400 mg (36%) FEDR 500 mg (34%) Placebo (7%) | FEDR 400 mg (26% of 90 evaluable) |
| Toxicity | Grade 1-2 GI toxicities Grade 3-4 cytopenias Suspected WE (more so in 500-mg arm) led to trial hold | Consistent with JAKARTA study toxicity • Low-grade GI TOX • Grade 3-4 anemia/thrombocytopenia |
| . | JAKARTA1 (frontline)23 . | JAKARTA2 (second line)24 . |
|---|---|---|
| Design | Phase 3/randomized PB controlled | Single arm |
| Dosing/arms | Placebo FEDR 400 mg FEDR 500 mg | FEDR 400 mg |
| Inclusion | Disease: primary, post-ET/PV MF Risk: DIPSS INT-2, high risk Prior RX: JAK-inhibitor naive | Disease: primary, post-ET/PV MF Risk: DIPSS INT-1 (symptomatic), INT-2, high risk Prior RX: ruxolitinib intolerant/refractory |
| Primary end point | >35% SVR | >35% SVR |
| Key secondary end point | ≥50% reduction in MFSAF-TSS | ≥50% reduction in MFSAF-TSS |
| Enrollment | N = 289 | N = 97 |
| Initial published response rates | ||
| Spleen volume response (>35% volume reduction) | FEDR 400 mg (36%) FEDR 500 mg (40%) Placebo (1%) | FEDR 400 mg (55% of 83 evaluable) |
| MFSAF-TSS (>50% reduction) | FEDR 400 mg (36%) FEDR 500 mg (34%) Placebo (7%) | FEDR 400 mg (26% of 90 evaluable) |
| Toxicity | Grade 1-2 GI toxicities Grade 3-4 cytopenias Suspected WE (more so in 500-mg arm) led to trial hold | Consistent with JAKARTA study toxicity • Low-grade GI TOX • Grade 3-4 anemia/thrombocytopenia |
DIPSS INT-1/-2, Dynamic International Prognostic Scoring System–Intermediate-1/–Intermediate-2; ET, essential thrombocythemia; FEDR, fedratinib; MFSAF-TSS, Myelofibrosis Symptom Assessment Form–total symptom score; PB, peripheral blood; PV, polycythemia vera; RX, prescription; TOX, toxicity.