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EFFICACY IN JAKi-NAÏVE PATIENTS WITH ANEMIA

Not an actual patient.

Efficacy results were assessed in a subset of patients who had anemia (Hb <10 g/dL) at baseline (n=181).1

  • The efficacy of OJJAARA in the treatment of patients with myelofibrosis in SIMPLIFY-1 was based on spleen volume reduction (SVR) (≥35%)*

*SVR response rate 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.

SIMPLIFY-1 clinical trial results

    Comparable rates of SVR ≥35% were observed with OJJAARA and ruxolitinib1,5

    Efficacy results were assessed in a subset of patients who had anemia (Hb <10 g/dL) at baseline (n=181).
    Chart of Subset Analysis of Patients With Hb<10 g/dL at Baseline: Rate of SVR of ≥35% From Baseline at Week 24.

    Median duration of response* was 35.7 months (95% CI, 27.6 months-NR)5

    *These descriptive post hoc subgroup data for SVR ≥35% duration of response are not included in the OJJAARA USPI and are not powered to detect treatment differences. Any differences in baseline characteristics of the treatment groups are not accounted for.

    A numerically lower percent of patients (Hb <10 g/dL) treated with OJJAARA (25%) achieved a TSS reduction of ≥50% at Week 24 compared with ruxolitinib (36%).1

    Spleen volume percent change for each patient1

    Efficacy results were assessed in a subset of patients who had anemia (Hb <10 g/dL) at baseline (n=181).
    Chart of Subset Analysis of Patients with Hb<10 g/dL at Baseline: Percent Change in Spleen Volume for Each Patient from Baseline at Week 24.

    *Missing data rates for OJJAARA and ruxolitinib were 19% and 8%.

    Post hoc data: Rates of SVR ≥35% in patients taking OJJAARA with baseline platelet counts5

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. These data are not included in the USPI for OJJAARA.

     

     

    Limitations:

    • For descriptive use only; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    • Some subgroups included a smaller sample size
    Post Hoc Subset Analysis of Patients With Hb <10 g/dL at Baseline
    Rate of SVR ≥35% at Week 24
    Baseline Platelet Count Momelotinib ruxolitinib
    >200 x 109/L (n=37)
    22%    		 (n=47)
    49%
    ≥100 to <200 x 109/L (n=36)
    36%    		 (n=34)
    24%
    ≥50 to <100 x 109/L (n=13)
    46%    		 (n=13)
    0%

    Post hoc data: Mean daily doses during Week 1 by baseline platelet counts5

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. These data are not included in the USPI for OJJAARA.

     

    Limitations:

    • For descriptive use only; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    Post hoc pie charts of mean daily doses during study Week 1 by baseline platelet counts.

    For full dosage and administration information, please see the dosing page.

    *Per protocol, ruxolitinib dosing was aligned with prescribing information.

    Post hoc data: Rate of TI in patients with Hb <10 g/dL treated with OJJAARA or ruxolitinib3

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. These data are not included in the USPI for OJJAARA.

     

    Limitations:

    • Not adjusted for multiplicity; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    • Results are for descriptive use only
    Post Hoc Subset Analysis Chart of Patients with Hb<10 g/dL at Baseline: Rate of TI at Week 24
    • 72% (18/25) of patients taking OJJAARA who were TI at baseline were also TI at Week 24
    • 34% (14/41) of patients taking ruxolitinib who were TI at baseline were also TI at Week 24

    *One patient who received ruxolitinib was excluded from this analysis due to a missing hemoglobin value prior to randomization.

    Post hoc data: Dual SVR ≥35% + TI response in patients taking OJJAARA or ruxolitinib5

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. These data are not included in the USPI for OJJAARA.

     

    Limitations:

    • Not adjusted for multiplicity; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    • Results are for descriptive use only
    Post Hoc Subset Analysis of Patients with Hb<10 g/dL at Baseline: Dual SVR ≥35% + TI Response at Week 24

    Post hoc data: Percent of patients with Hb >10 g/dL by baseline anemia status4

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. These data are not included in the USPI for OJJAARA.

     

    Limitations:

    • For descriptive use only; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    Post hoc subset analysis chart of patients with moderate and severe anemia at baseline by Week 24 with Hb >10 g/dL.

    Among patients treated with OJJAARA, the median (range) time to first Hb >10 g/dL was:

    • Moderate anemia at baseline: 0.6 (0.4-5.1) months
    • Severe anemia at baseline: 1.4 (0.5-4.7) months

    *Moderate anemia defined as Hb ≥8 g/dL to <10 g/dL. Severe anemia defined as Hb <8 g/dL.

    Post hoc data: Mean hemoglobin and platelet levels over 24 weeks3,6

    These are post hoc subset data in patients who had Hb <10 g/dL at baseline. Data reflect mean hemoglobin levels and mean platelet levels over time, collected from patients with available laboratory data who remained in the study at each time point during the randomized treatment period. These data are not included in the USPI for OJJAARA.

     

    Limitations:

    • For descriptive use only; not powered to detect treatment differences
    • Differences in baseline characteristics not accounted for
    Post hoc data line graph of mean hemoglobin levels through Week 24.
    Post hoc data line graph of mean platelet levels through Week 24.
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    TOGETHER WITH GSK ONCOLOGY
    CI=confidence interval; CT=computed tomography; ET=essential thrombocythemia; Hb=hemoglobin; JAK=Janus kinase; JAKi=Janus kinase inhibitor; MF=myelofibrosis; MRI=magnetic resonance imaging; NR=not reached; PV=polycythemia vera; RBC=red blood cell.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    IMPORTANT SAFETY INFORMATION

    INDICATION

    OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

    IMPORTANT SAFETY INFORMATION

    Risk of Infections

    • Serious (including fatal) infections (e.g., bacterial and viral, including COVID-19) occurred in 13% of patients treated with OJJAARA. Infections regardless of grade occurred in 38% of patients. Delay starting therapy until active infections have resolved. Monitor patients for signs and symptoms of infection and initiate appropriate treatment promptly.

      Hepatitis B Reactivation
    • Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine transaminase (ALT) or aspartate transaminase (AST), have been reported in patients with chronic hepatitis B virus (HBV) infection taking Janus Kinase (JAK) inhibitors, including OJJAARA. The effect of OJJAARA on viral replication in patients with chronic HBV infection is unknown. In patients with HBV infections, check hepatitis B serologies prior to starting OJJAARA. If HBsAg and/or anti-HBc antibody is positive, consider consultation with a hepatologist regarding monitoring for reactivation versus prophylactic hepatitis B therapy. Patients with chronic HBV infection who receive OJJAARA should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.

    Thrombocytopenia and Neutropenia

    • New or worsening thrombocytopenia, with platelet count less than 50 × 109/L, was observed in 20% of patients treated with OJJAARA. Eight percent of patients had baseline platelet counts less than 50 × 109/L.
    • Severe neutropenia, absolute neutrophil count (ANC) less than 0.5 × 109/L, was observed in 2% of patients treated with OJJAARA.
    • Assess complete blood counts (CBC), including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated. Interrupt dosing or reduce the dose for thrombocytopenia or neutropenia.

    Hepatotoxicity

    • Two of the 993 patients with MF who received at least one dose of OJJAARA in clinical trials experienced reversible drug-induced liver injury. Overall, new or worsening elevations of ALT and AST (all grades) occurred in 23% and 24%, respectively, of patients treated with OJJAARA; Grade 3 and 4 transaminase elevations occurred in 1% and 0.5% of patients, respectively. New or worsening elevations of total bilirubin occurred in 16% of patients treated with OJJAARA. All total bilirubin elevations were Grades 1-2. The median time to onset of any grade transaminase elevation was 2 months, with 75% of cases occurring within 4 months.
    • Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated. When initiating OJJAARA, refer to dosing in patients with hepatic impairment.
    • Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, modify OJJAARA dosage based upon Table 1 within the Prescribing Information.

    Severe Cutaneous Adverse Reactions (SCARs)

    • Severe cutaneous adverse reactions (SCARs), including toxic epidermal necrolysis (TEN), have been observed in some patients treated with OJJAARA.
    • If signs or symptoms of SCARs occur, interrupt OJJAARA until the etiology of the reaction has been determined. Consider early consultation with a dermatologist for evaluation and management.
    • If etiology is considered to be associated with OJJAARA, permanently discontinue OJJAARA and do not reintroduce OJJAARA in patients who have experienced SCARs or other life-threatening cutaneous reactions during treatment with OJJAARA.

    Major Adverse Cardiovascular Events (MACE)

    • Another JAK inhibitor increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke [compared with those treated with tumor necrosis factor (TNF) blockers] in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated.
    • Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients receiving OJJAARA of the symptoms of serious cardiovascular events and the steps to take if they occur.

    Thrombosis

    • Another JAK inhibitor increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Evaluate patients with symptoms of thrombosis and treat appropriately.

    Malignancies

    • Another JAK inhibitor increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Current or past smokers were at increased risk.
    • Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

    Adverse Reactions

    • The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

    Organic Anion Transporting Polypeptide (OATP)1B1/B3 Inhibitors

    • Momelotinib is an OATP1B1/B3 substrate. Concomitant use with an OATP1B1/B3 inhibitor increases momelotinib maximal concentrations (Cmax) and area under the concentration-time curve (AUC), which may increase the risk of adverse reactions with OJJAARA. Monitor patients concomitantly receiving an OATP1B1/B3 inhibitor for adverse reactions and consider OJJAARA dose modifications.

    Breast Cancer Resistance Protein (BCRP) Substrates

    • Momelotinib is a BCRP inhibitor. OJJAARA may increase exposure of BCRP substrates, which may increase the risk of BCRP substrate adverse reactions. When administered concomitantly with OJJAARA, initiate rosuvastatin (BCRP substrate) at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed. Follow approved product information recommendations for other BCRP substrates.

    Pregnancy

    • Available data in pregnant women are insufficient. OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.

    Lactation

    • It is not known whether OJJAARA is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed child, patients should not breastfeed during treatment with OJJAARA, and for at least 1 week after the last dose of OJJAARA.

    Females and Males of Reproductive Potential

    • Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for at least 1 week after the last dose of OJJAARA.

    Hepatic Impairment

    • Momelotinib exposure increased with severe hepatic impairment (Child-Pugh C). The recommended starting dose of OJJAARA in patients with severe hepatic impairment (Child-Pugh C) is 150 mg orally once daily. No dose modification is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).

    Please see full Prescribing Information for OJJAARA.

    To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
    FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    References

    1. OJJAARA (momelotinib). Prescribing Information. GSK; 2025.
    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. Gupta V, Oh S, Devos T, et al. Momelotinib vs. ruxolitinib in myelofibrosis patient subgroups by baseline hemoglobin levels in the SIMPLIFY-1 trial. Leuk Lymphoma. 2024;65(7):965-977. doi:10.1080/10428194.2024.2328800
    4. Palandri F, O’Connell C, Vachhani P, et al. Survival impact and kinetics of hemoglobin improvement with momelotinib in patients with myelofibrosis and moderate to severe anemia: post hoc analyses of SIMPLIFY-1 and MOMENTUM. Poster presented at the European Hematology Association 2025 Congress, Milan, Italy, June 12-15, 2025. Poster PF828.
    5. Palandri F, Schaap NPM, Rey J, et al. Impact of dual spleen response and transfusion independence on survival in JAK inhibitor–naive patients with myelofibrosis and anemia treated with momelotinib: a subgroup analysis of SIMPLIFY-1. Poster presented at the European Hematology Association 2025 Congress, Milan, Italy, June 12-15, 2025. Poster PS1829.
    6. Gupta V, Oh S, Devos T, et al. Momelotinib vs. ruxolitinib in myelofibrosis patient subgroups by baseline hemoglobin levels in the SIMPLIFY-1 trial. Supplement. Leuk Lymphoma. 2024;65(7):965-977. doi:10.1080/10428194.2024.2328800
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