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EFFICACY IN JAKi-EXPERIENCED PATIENTS WITH ANEMIA

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MOMENTUM clinical trial results

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

    Primary Endpoint: TSS Reduction of greater than or equal to 50 percent 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 myelofibrosis: 

    • 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)
    • *Analysis 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 Baseline and Week 24
    • *Analysis stratified by baseline RBC or whole blood units transfused in the 8-week period before randomization (0, 1-4, ≥5 units).
    • †Noninferiority 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 Transfusions at Week 24
    • *Least squares means and difference are reported.
    • †Eight patients treated with OJJAARA and 3 patients treated with danazol had no transfusion, but discontinued treatment prior to Week 24.
    • ‡Analysis 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 about 7x greater with OJJAARA vs danazol1

    Secondary Endpoint: SVR of greater than or equal to 35 percent at Week 24.
    • *Analysis stratified by baseline palpable spleen length below the left costal margin (<12 vs ≥12 cm).

    Post hoc data at Week 48 in patients who received open-label OJJAARA3

    These analyses were based upon data from the open-label extension (OLE) period (Week 24 to Week 48). These data are not included in the USPI for OJJAARA.

    Limitations:

    • There is potential for enrichment of data in this population due to inherent biases of the open-label crossover design, since patients who did not tolerate the drug or did not respond may not have enrolled in the open-label phase
    • Data were missing for patients who discontinued or did not complete the Week 48 visit, excluding them from the denominator in these observational analyses. The impact of patients with missing Week 48 data is unknown, but there is potential for enrichment of the data
    • Due to the open-label crossover design, there was no randomization, no blinding, and no comparator arm from Week 24 to Week 48
    • These descriptive data are not adjusted for multiplicity and not powered to show statistical significance
    Post hoc TSS response rate of greater than or equal to a 50 percent reduction at Week 48.

    *TSS response at Week 48, defined as reaching ≥50% mean reduction compared with baseline over the last 28 days before the end of Week 48 (the MFSAF was administered daily for 1 week every month during the open-label period).  

    Post hoc TI rate at Week 48.

    ‡TI rate at Week 48, defined as the proportion of patients with no transfusions or Hb <8 g/dL in the last 12 weeks of treatment.

    Post hoc SVR response rate of greater than or equal to 35 percent at Week 48.

    §SVR response rate at Week 48, defined as the proportion of patients who had ≥35% reduction in spleen volume from baseline on imaging at Week 48. 

    • †Percentages were based on number of patients who entered the open-label period and provided sufficient data for evaluation for all endpoints at Week 48; this was 67/93 patients in the OJJAARA group who chose to continue treatment and 30/41 patients in the danazol group who chose to cross over to OJJAARA.

    Week 24 nonresponders (n=72 evaluable patients) with TSS reduction ≥50% by Week 48 (using rolling definition of TSS||)

    • 38% (n=17/45) of Week 24 TSS nonresponders receiving OJJAARA who continued open-label OJJAARA became TSS responders by Week 48
    • 52% (n=14/27) of Week 24 TSS nonresponders who crossed over from danazol to OJJAARA became TSS responders by Week 48

    Week 24 nonresponders (n=72 evaluable patients) with TI response by Week 48 (using rolling definition of TI)

    • 21% (n=10/48) of TI nonresponders receiving OJJAARA who continued open-label OJJAARA became TI responders by Week 48
    • 42% (n=10/24) of TI nonresponders who crossed over from danazol to OJJAARA became TI responders by Week 48

    Week 24 nonresponders (n=71 evaluable patients) with SVR ≥35% at Week 48#

    • 23% (n=10/43) of SVR nonresponders receiving OJJAARA who continued open-label OJJAARA became SVR responders at Week 48
    • 11% (n=3/28) of SVR nonresponders who crossed over from danazol to OJJAARA became SVR responders at Week 48
    • ||TSS response by Week 48, defined as reaching ≥50% mean reduction compared with baseline over any rolling 28-day period during the open-label period up to Week 48.
    • TI response by Week 48, defined as reaching these criteria (no transfusion or Hb <8 g/dL) over any rolling 12-week period during the open-label period up to Week 48.
    • #SVR response rate at Week 48, defined as the proportion of patients who had ≥35% reduction in spleen volume from baseline on imaging at Week 48.
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    CI=confidence interval; CT=computed tomography; ET=essential thrombocythemia; Hb=hemoglobin; IQR=interquartile range; JAK=Janus kinase; JAKi=Janus kinase inhibitor; MF=myelofibrosis; MFSAF=Myelofibrosis Symptom Assessment Form; MRI=magnetic resonance imaging; 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.

    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; 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
    3. Gerds AT, Verstovsek S, Vannucchi AM, et al. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023;10(9):e735-e746. doi:10.1016/S2352-3026(23)00174-6
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