SIMPLIFY-1 is supportive data and should be evaluated along with the pivotal MOMENTUM trial data

Please see MOMENTUM efficacy study data.

Efficacy results were assessed in a subset of patients who had anemia (Hb <10 g/dL) at baseline (n=181).

  • The efficacy of OJJAARA in the treatment of patients with MF in SIMPLIFY-1 was based on SVR (reduction ≥35%)*
  • A numerically lower percent of patients treated with OJJAARA (25%) achieved a TSS reduction of ≥50% at Week 24 compared with ruxolitinib (36%)

SIMPLIFY-1 clinical trial results

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  • View SIMPLIFY-1 Study Design

    SIMPLIFY-1: OJJAARA was studied in the only head-to-head MF trial vs ruxolitinib1,2†

    JAKi-Naïve Patients (N=432)

    SIMPLIFY-1 study design infographic

    SIMPLIFY-1 was a double-blind, randomized, active-controlled Phase 3 study in 432 patients with primary MF, post-PV MF, or post-ET MF who had not previously received a JAK inhibitor.

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

    Other studies of JAK MF therapies have compared with Best Available Therapy (BAT). The BAT arm in those studies has included ruxolitinib.3

    Palpable splenomegaly ≥5 cm below the left costal margin.2

  • View SIMPLIFY-1 Patient Baseline Characteristics

    Baseline patient characteristics1

    8.8 median Hb count in patients with Hb <10g/dL vs. 193 median platelet count in patients with Hb <10 g/dL

    Patients With Baseline Hb <10 g/dL (n=181)

    Median age, years (range) 68 (25 to 86)
    ≥65 years of age 67%
    Male, Female 59%, 41%
    White, Asian, Black, Hispanic or Latino 81%, 8%, 1%, 2%
    Primary MF, Post-PV, Post-ET 63%, 13%, 24%
    Intermediate-1 risk, Intermediate-2 risk, High-risk§ 4%, 25%, 71%
    Transfusion independent|| 29% in the OJJAARA treatment arm, 44% in the ruxolitinib treatment arm
    Median Hb, g/dL 8.8
    Median platelet count, × 109/L (range) 193 (54 to 2865)
    Median palpable spleen length 12 cm below the left costal margin
    Median central spleen volume, MRI or CT, cm3 (range) 1843 (352 to 9022)

    §As defined by the International Prognostic Scoring System (IPSS) for MF.1

    ||TI at baseline, defined as no RBC transfusions and all Hb ≥8 g/dL in the 12 weeks prior to randomization.4

Comparable rates of SVR ≥35% were observed with OJJAARA and ruxolitinib1

Subset Analysis of Patients With Hb <10 g/dL at Baseline: Rate of SVR ≥35% From Baseline at Week 24

Chat of Subset Analysis of Patients With Hb<10 g/dL at Baseline: Rate of SVR of ≥35% From Baseline at Week 24
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CI=confidence interval; CT=computed tomography; ET=essential thrombocythemia; Hb=hemoglobin; JAKi=Janus kinase inhibitor; MF=myelofibrosis; MRI=magnetic resonance imaging; PV=polycythemia vera; RBC=red blood cell.


  1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
  2. Mesa RA, Kiladjian JJ, Catalano JV, et al. SIMPLIFY-1: a phase III randomized trial of momelotinib versus ruxolitinib in Janus kinase inhibitor-naïve patients with myelofibrosis. J Clin Oncol. 2017;35(34):3844-3850. doi:10.1200/JCO.2017.73.4418
  3. Sureau L, Orvain C, Ianotto JC, et al. Efficacy and tolerability of Janus kinase inhibitors in myelofibrosis: a systematic review and network meta-analysis. Blood Cancer J. 2021;11(7):135. doi:10.1038/s41408-021-00526-z
  4. Data on file, GSK.