Summary phase 3 clinical trial data for JAK inhibitors used for MF therapy
| Trial . | n* . | Treatment arm(s) . | Control arm . | Prior JAK inhibitor allowed? . | Median follow-up (median drug exposure) . | Study drug discontinuation rate . | Dose modifications† . | Spleen volume response‡ . | Symptom response . |
|---|---|---|---|---|---|---|---|---|---|
| COMFORT-I | 155 | Ruxolitinib | Placebo | No | 268 wk (149 wk) | 72% | 57% | 42%; P < .001 | 46%; P < .001 |
| COMFORT-II | 146 | Ruxolitinib | BAT | No | 4.7 y (2.6 y) | 73% | n.a. | 28%; P < .001 | Not applicable |
| JAKARTA | 193 | Fedratinib,400 mg QD,500 mg QD | Placebo | No | n.a. (30 wk, 400 mg) (28 wk, 500 mg) | 25%, 400 mg | 24%, 400 mg | 36%, 400 mg; P < .001 | 36%, 400 mg; P < .001 |
| 33%, 500 mg | 37%, 500 mg | 40%, 500 mg; P < .001 | 34%, 500 mg; P < .001 | ||||||
| PERSIST-I | 220 | Pacritinib,400 mg QD | BAT | No | 22.9 mo (15.6 mo) | 59%§ | 47% | 19%; P = .0003 | 19%, 0.24 |
| PERSIST-II | 211 | Pacritinib,400 mg QD,200 mg BID | BAT, including ruxolitinib, 45% | Yes | n.a. (24 wk) | 40%, QD§ | 20%, QD | 15% QD; P = .02 | 17% QD; P = .7 |
| 29%, BID§ | 12%, BID | 22% BID; P = .001 | 32% BID; P = .01 | ||||||
| SIMPLIFY-I | 215 | Momelotinib,200 mg QD | Ruxolitinib,20 mg BID | No | 24 wk (21 wk) | 19% | 26% | 27%, noninferiority | 28%, noninferiority |
| Met; P = .01 | Not met; P = .98 | ||||||||
| SIMPLIFY-II | 104 | Momelotinib,200 mg QD | BAT, including ruxolitinib, 88% | Yes | 168 d (19.5 wk) | 34% | 16% | 7%; P = .9 | 26%; P = .0006 |
| Trial . | n* . | Treatment arm(s) . | Control arm . | Prior JAK inhibitor allowed? . | Median follow-up (median drug exposure) . | Study drug discontinuation rate . | Dose modifications† . | Spleen volume response‡ . | Symptom response . |
|---|---|---|---|---|---|---|---|---|---|
| COMFORT-I | 155 | Ruxolitinib | Placebo | No | 268 wk (149 wk) | 72% | 57% | 42%; P < .001 | 46%; P < .001 |
| COMFORT-II | 146 | Ruxolitinib | BAT | No | 4.7 y (2.6 y) | 73% | n.a. | 28%; P < .001 | Not applicable |
| JAKARTA | 193 | Fedratinib,400 mg QD,500 mg QD | Placebo | No | n.a. (30 wk, 400 mg) (28 wk, 500 mg) | 25%, 400 mg | 24%, 400 mg | 36%, 400 mg; P < .001 | 36%, 400 mg; P < .001 |
| 33%, 500 mg | 37%, 500 mg | 40%, 500 mg; P < .001 | 34%, 500 mg; P < .001 | ||||||
| PERSIST-I | 220 | Pacritinib,400 mg QD | BAT | No | 22.9 mo (15.6 mo) | 59%§ | 47% | 19%; P = .0003 | 19%, 0.24 |
| PERSIST-II | 211 | Pacritinib,400 mg QD,200 mg BID | BAT, including ruxolitinib, 45% | Yes | n.a. (24 wk) | 40%, QD§ | 20%, QD | 15% QD; P = .02 | 17% QD; P = .7 |
| 29%, BID§ | 12%, BID | 22% BID; P = .001 | 32% BID; P = .01 | ||||||
| SIMPLIFY-I | 215 | Momelotinib,200 mg QD | Ruxolitinib,20 mg BID | No | 24 wk (21 wk) | 19% | 26% | 27%, noninferiority | 28%, noninferiority |
| Met; P = .01 | Not met; P = .98 | ||||||||
| SIMPLIFY-II | 104 | Momelotinib,200 mg QD | BAT, including ruxolitinib, 88% | Yes | 168 d (19.5 wk) | 34% | 16% | 7%; P = .9 | 26%; P = .0006 |