Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
4.4 YEARS MEDIAN DURATION OF SPLEEN RESPONSE AMONG PRIMARY RESPONDERS (n=65)3†
Primary Endpoint Results
Each bar represents an individual patient's response.
From New England Journal of Medicine, Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind,
placebo-controlled trial of ruxolitinib for myelofibrosis, 366(9), 799-807. Copyright © 2012
Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
of patients experienced some reduction in spleen volume on Jakafi2,4
Most patients receiving placebo experienced an increase in
spleen volume.1,2
Significantly more patients achieved a ≥50% improvement in Total Symptom Score compared with placebo
MEDIAN TIME TO SYMPTOM RESPONSE WAS <4 WEEKS FOR PATIENTS RECEIVING JAKAFI1
Worsening of TSS is truncated at 150%.1
From New England Journal of Medicine, Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind,
placebo-controlled trial of ruxolitinib for myelofibrosis, 366(9), 799-807. Copyright ©
2012Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
of patients experienced some improvement in symptoms on Jakafi3
Most patients receiving placebo had worsening of symptoms.2
Debilitating Symptoms of MF1,2
- Abdominal discomfort
- Early satiety
- Pain under left ribs
- Pruritus
- Night sweats
- Bone/muscle pain
Jakafi 5-year overall survival data
COMFORT-I 5-year analysis6: Jakafi and placebo
- At 3 years, survival probability was 70% for patients originally randomized to Jakafi and 61% for those originally randomized to placebo1
- Overall survival was a prespecified secondary endpoint in COMFORT-I1
aThe 5-year overall survival analysis is not included in the Full Prescribing Information for Jakafi. Although the 3-year overall survival analysis is presented in the Full Prescribing Information, P values and hazard ratios are omitted from the overall survival Kaplan-Meier curves.3
bCOMFORT-I was not designed to compare survival probabilities between Jakafi and placebo at 3 or 5 years.3
cPatients randomized to placebo were eligible to cross over to receive Jakafi because of progression-driven events or at the physician’s discretion; however, these patients continued to be grouped within their original randomized assignment for analysis purposes.3
COMFORT-II 5-year analysis7: Jakafi and best available therapy
- At 3 years, survival probability was 79% for patients originally randomized to Jakafi and 59% for those originally randomized to best available therapy1
- Overall survival was a prespecified secondary endpoint in COMFORT-II1
BAT, best available therapy.
aThe 5-year overall survival analysis is not included in the Full Prescribing Information for Jakafi. Although the 3-year overall survival analysis is presented in the Full Prescribing Information, P values and hazard ratios are omitted from the overall survival Kaplan-Meier curves.3
bCOMFORT-II was not designed to compare survival probabilities between Jakafi and best available therapy at 3 or 5 years.3
cPatients randomized to best available therapy were eligible to cross over to receive Jakafi because of progression-driven events or at the physician’s discretion; however, these patients continued to be grouped within their original randomized assignment for analysis purposes.3
Video
Video
Jakafi® (ruxolitinib) in Intermediate-2 or High-Risk Myelofibrosis (MF): Spleen Volume, Symptom, and Overall Survival Data
Hematologist-oncologist Dr Gary Grad reviews data from the COMFORT¶ trials in MF, which included patients with intermediate-2 or high-risk myelofibrosis. Dr Grad begins with a discussion of risk level and corresponding survival in MF. He then discusses results including reduction in spleen volume, symptom reduction (COMFORT-I only), and overall survival probability (which was a secondary endpoint in both trials).
¶COMFORT, COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment
*COMFORT-I (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-I) was a randomized, double-blind, placebo-controlled phase 3 study with 309 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline to week 24 as measured by computed tomography (CT) or magnetic resonance imaging (MRI).1,2
Duration of spleen response was defined as the interval between the first spleen response measurement that was a ≥35% reduction from baseline and the date of the first measurement that was no longer a ≥35% reduction from baseline that was also a >25% increase from nadir.3
COMFORT-II (COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment-II) was a randomized, open-label phase 3 study with 219 patients with intermediate-2–risk or high-risk MF. The primary endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline at week 48 as measured by CT or MRI.1,5
§Best available therapy in COMFORT-II included hydroxyurea (46.6%) and glucocorticoids (16.4%), as well as no medication, anagrelide, epoetin alfa, thalidomide, lenalidomide, mercaptopurine, thioguanine, danazol, peginterferon alfa-2a, interferon-α, melphalan, acetylsalicylic acid, cytarabine, and colchicine.3
||A secondary endpoint was the proportion of patients with a ≥50% reduction in TSS from baseline to week 24 as measured by the daily patient diary, the modified Myelofibrosis Symptom Assessment Form. TSS encompasses core symptoms of MF: abdominal discomfort, early satiety, pain under left ribs, pruritus, night sweats, and bone/muscle pain. Symptom scores ranged from 0 to 10, with 0 representing symptoms “absent" and 10 representing symptoms “worst imaginable." These scores were added to create the daily total score, which has a maximum of 60. At baseline, mean TSS was 18.0 in the group receiving Jakafi and 16.5 in the group receiving placebo.1,2
