EFFICACY IN JAKi-EXPERIENCED PATIENTS WITH ANEMIA

  • Total Symptom Score (TSS)
  • Rate of Transfusion Independence (TI)
  • Rate of No Transfusions
  • Spleen Volume Reduction (SVR)

MOMENTUM clinical trial results

Hide allShow all

  • View MOMENTUM Study Design

    MOMENTUM: Head-to-head trial evaluating OJJAARA vs danazol1,2

    JAKi-Experienced Patients With MF Who Were Symptomatic and Anemic (N=195)*

    MOMENTUM study design infographic

    MOMENTUM was a double-blind, randomized, active-controlled Phase 3 trial in 195 symptomatic and anemic patients with primary MF, post-PV MF, or post-ET MF who had been previously treated with an approved JAK inhibitor therapy.

    Primary Endpoint1,2

    • TSS response rate§ (≥50% reduction) (superiority)

    Select Key Secondary Endpoints1,2

    • TI rate|| (noninferiority)
    • Rate of no transfusions (superiority)
    • SVR response rate# (≥35%) (superiority)

    *JAKi-experienced, defined as previously treated with an approved JAKi for ≥90 days or ≥28 days if therapy was complicated by ≥4 units of RBC transfused in 8 weeks, or Grade 3 or 4 adverse events of thrombocytopenia, anemia, or hematoma. Symptomatic and anemic, defined as a Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 TSS of ≥10 at screening, and Hb <10 g/dL, respectively.2

    †Baseline splenomegaly, defined as a palpable spleen of ≥5 cm below the left costal margin or volume of ≥450 cm3 on imaging.2

    ‡Patients receiving JAKi therapy at screening tapered therapy over more than 1 week, then completed at least 2 weeks of no treatment, starting at least 7 days before baseline assessments.2

    §TSS response rate at Week 24 was defined as the proportion of patients who achieved ≥50% TSS reduction over the 28 days immediately prior compared with their own baseline score. TSS was measured using the MFSAF v4.0.1,2

    ||TI rate at Week 24 was defined as the proportion of patients with no transfusion or Hb <8 g/dL between Weeks 12 and 24.1

    Rate of no transfusions at Week 24 was defined as the proportion of patients with no transfusions during the 24-week treatment period.1

    #SVR rate at Week 24 was defined as the proportion of patients who had a ≥35% reduction in spleen volume from baseline. Spleen volume was measured by MRI or CT.1,2

  • View MOMENTUM Patient Baseline Characteristics

    Baseline patient characteristics1

    8.0 median Hb in the OJJAARA treatment arm

     

    Characteristic

    Overall Population (N=195)
    Median age, years (range) 71 (38 to 86)
    ≥65 years of age 79%
    Male, Female 63%, 37%
    White, Asian, Black, Hispanic or Latino 81%, 9%, 2%, 6%
    Primary MF, Post-PV, Post-ET 64%, 19%, 17%
    Intermediate-1 risk, Intermediate-2 risk, High-risk** 5%, 57%, 35%
    Received RBC transfusion within 8 weeks prior to treatment 79% (Median of 4 RBC units; IQR: 1-6)
    Transfusion independent†† 13% in OJJAARA treatment arm, 15% in danazol treatment arm
    Median Hb, g/dL 8
    Median platelet count, × 109/L (range)  96 (24 to 733)
    Median palpable spleen length  11 cm below the left costal margin
    Median central spleen volume, MRI or CT, cm3 (range) 2105 (609 to 9717)
    Mean TSS, MFSAF v4.0 28 in OJJAARA treatment arm, 26 in danazol treatment arm

    **As defined by the Dynamic International Prognostic Scoring System (DIPSS) for MF.1

    ††TI at baseline, defined as no RBC transfusions in the 12 weeks before the first dose and Hb ≥8 g/dL.1

Achievement of ≥50% TSS reduction was almost 3x greater with OJJAARA vs danazol1

Primary Endpoint: Rate of TSS Reduction of ≥50% From Baseline at Week 24

Primary Endpoint: TSS Reduction of ≥50% at Week 24

Symptoms were measured using the MFSAF v4.0 diary. The MFSAF v4.0 patient diary, completed throughout the randomized treatment period, captured the core symptoms of MF: 

  • Fatigue, night sweats, itching, abdominal discomfort, pain under ribs on left side, feeling of fullness after beginning to eat, and bone pain
  • For each item, symptom scores, ranging from 0 (absent) to 10 (worst imaginable), were added to create a daily TSS (maximum score of 70)

aAnalysis stratified by baseline MFSAF v4.0 TSS (<22 vs ≥22).

30% of patients achieved TI with OJJAARA at Week 241,2

TI rate with OJJAARA was statistically noninferior to danazol.

Secondary Endpoint: Rate of TI at Week 24 (No Transfusion or Hb <8 g/dL Between Weeks 12 and 24)

Secondary Endpoint: TI at Baseline and Week 24

Baseline data provided as contextual information.

aAnalysis stratified by baseline RBC or whole blood units transfused in the 8-week period before randomization (0, 1-4, ≥5 units).

bNoninferiority difference between OJJAARA response rate and 80% of danazol response rate.

Achievement of no transfusions was about 2x greater with OJJAARA vs danazol1

Secondary Endpoint: Rate of No Transfusionsa,b (During the 24-Week Treatment Period)

Secondary Endpoint: No Transfusion Rate at Week 24

aLeast squares means and difference are reported.

bEight patients treated with OJJAARA and 3 patients treated with danazol had no transfusion, but discontinued treatment prior to Week 24.

cAnalysis stratified by baseline RBC or whole blood units transfused in the 8-week period before randomization (0, 1-4, ≥5 units).

Achievement of ≥35% SVR was almost 7x greater with OJJAARA vs danazol1

Secondary Endpoint: Rate of SVR ≥35% From Baseline at Week 24

Secondary Endpoint: SVR of ≥35% at Week 24

aAnalysis stratified by baseline palpable spleen length below the left costal margin (<12 vs ≥12 cm).

SEE HOW OJJAARA PERFORMED IN JAKi-NAÏVE PATIENTS

Safety profile icon blue

Explore the safety profile of OJJAARA

REVIEW SAFETY PROFILE

Support icon

Find access and support information

TOGETHER WITH GSK

CI=confidence interval; CT=computed tomography; ET=essential thrombocythemia; Hb=hemoglobin; IQR=interquartile range; JAKi=Janus kinase inhibitor; MF=myelofibrosis; MFSAF=Myelofibrosis Symptom Assessment Form; MRI=magnetic resonance imaging; PV=polycythemia vera; RBC=red blood cell.

References

  1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
  2. Verstovsek S, Gerds AT, Vannucchi AM, et al; MOMENTUM Study Investigators. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. Lancet. 2023;401(10373):269-280. doi:10.1016/S0140-6736(22)02036-0