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INGRAIN-MF
Incorporating genetics, risk and associated burden into MF management

MODULE 4: Optimising management of myelofibrosis and evaluating the use of JAK inhibitors

Fedratinib and momelotinib for disease-related symptoms and splenomegaly in MF

The efficacy and safety profiles of fedratinib and momelotinib in patients with myelofibrosis (MF) were assessed in clinical trials:

JAKARTA trial1

Fedratinib 400 mg* OD (n=96)
vs
placebo (n=96)

Patients with intermediate-2 or high‑risk primary MF, post‑PV, or post‑ET MF

JAKARTA trial data  

SIMPLIFY-1 trial2

Momelotinib 200 mg OD (n=214)
vs
ruxolitinib 20 mg BD (n=216)

JAK inhibitor-naive patients with symptomatic intermediate‑1, intermediate‑2 or high‑risk MF

SIMPLIFY-1 trial data  

Comparisons should not be made between the JAKARTA and SIMPLIFY-1 trials. Data presented here are to show independent key outcomes within each trial.

*The JAKARTA trial also studied the efficacy and safety profile of fedratinib 500 mg (n=97).1 The recommended dose of fedratinib is 400 mg daily.3

BD: twice daily; ET: essential thrombocythaemia; JAK: janus kinase; MF: myelofibrosis; OD: once daily; PV: polycythaemia vera

JAKARTA trial results at Week 241

Proportion of patients achieving ≥35% reduction in spleen volume from baseline

(primary endpoint)

Fedratinib 400 mg Placebo
36%
n=35/96
95% CI: 27%-46% 		1%
n=1/96
95% CI: 0%-3%
p<0.001

Proportion of patients achieving ≥50% reduction in total symptom score† from baseline

(key secondary endpoint)

Fedratinib 400 mg Placebo
36%
n=33/91
95% CI: 26%-46% 		7%
n=6/85
95% CI: 2%-13%
p<0.001

†Assessed using the modified Myelofibrosis Symptom Assessment Form

The fedratinib group showed clinically and statistically significant differences vs placebo in the achievement of ≥35% reduction in spleen volume and ≥50% reduction in total symptom scores.1

Safety profile and tolerability of fedratinib

Among patients with MF treated with a 400 mg dose of fedratinib in several clinical studies (n=203), the most frequently reported adverse events were:3

Haematological AEs

Non-haematological AEs

Discontinuation due to adverse events, regardless of causality, was observed in 24% of patients receiving 400 mg of fedbratinib.3

SIMPLIFY-1 trial results at Week 242

Proportion of patients achieving ≥35% reduction in spleen volume from baseline

(primary endpoint)

Momelotinib Ruxolitinib
26.5%
(n=57/215) 		29.0%
(n=63/217)
Non-inferiority proportion difference: 0.09
95% CI: 0.02-0.16
p=0.11 for non-inferiority

Proportion of patients achieving ≥50% reduction in total symptom score from baseline

(key secondary endpoint)

Momelotinib Ruxolitinib
28.4%
(n=60/211) 		42.2%
(n=89/211)
Non-inferiority proportion difference: 0.09
95% CI: -0.08 to 0.08
p=0.98; non-inferiority was not met

Momelotinib was non-inferior to ruxolitinib in spleen response; momelotinib was not non-inferior to ruxolitinib at symptom control.

Safety and tolerability profiles of momelotinib and ruxolutinib2

The most common treatment-emergent AEs (TEAEs) occurring in ≥10% of either treatment group in SIMPLIFY-1 (n=214 for momelotinib group; n=216 for ruxolitinib):

Haematological TEAEs

Momelotinib Ruxolitinib
Thrombocytopenia 18.7% 29.2%
Anaemia 13.6% 38.0%

Haematological TEAEs

Momelotinib Ruxolitinib
Diarrhoea 17.8% 19.9%
Nausea 15.9% 3.7%
Abdominal pain 10.3% 11.1%

Other TEAEs

Momelotinib Ruxolitinib
Headache 17.3% 19.9%
Dizziness 15.9% 11.6%
Fatigue 14.5% 12.0%

Treatment discontinuation was reported for 18.6% of patients in the momelotinib group and 7.4% in the ruxolitinib group.2

The safety profile of momelotinib in patients with MF showed fewer events of anaemia and thrombocytopenia compared with ruxolitinib and a higher incidence of nausea.2

Continue to next section: Ruxolutinib for treating disease-related symptoms and splenomegaly in MF 
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report or alternatively email medinfo.uk@novartis.com or call 01276 698370

References
  1. Pardanani A, Harrison C et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. JAMA Oncol 2015;1:643-651
  2. Mesa R A, Kiladjian J J et al. SIMPLIFY-1: a phase III randomized trial of momelotinib versus ruxolitinib in janus kinase inhibitor-naive patients with myelofibrosis. J Clin Oncol 2017;35:3844-3850
  3. Inrebic®▼ (fedratinib) Summary of Product Characteristics. Available at: medicines.org.uk. Accessed August 2025