Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-Fibrotic Primary Myelofibrosis and DIPSS Low/Intermediate-1 Risk Myelofibrosis

Gill, Harinder; Au, Lester; Yim, Rita; Chin, Lynn; Li, Vivian; Lee, Paul; Leung, Gilberto Ka Kit; Lee, Carmen; Wu, Tony Kwun Yat; Ngai, Cheong; Ho, Ryan; Sin, Albert Chun Fung; Hou, Hsin‐An; Chen, Chih‐Cheng; Kwong, Yok-Lam

doi:10.1182/blood-2022-169613

Cited by 3 publications

(8 citation statements)

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“… 65 Clinicohematologic CR in patients at 12 weeks ( n = 46) and 24 weeks ( n = 30) was 74% and 67%, respectively. 64 Responses in hemoglobin (defined as 10 g/dL to upper limit of normal), WBC (defined as WBC < 10 × 10 9 /L), and platelet (defined as platelet count ⩽400 × 10 9 /L) at 24 weeks were achieved in 76.6%, 87.2%, and 78.7% of patients, respectively. 65 JAK2 V617F allele burden was stable or improved in 92% (36/39) of patients with baseline JAK2 V617F mutation at 24 weeks.…”

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 94%

“…The phase II, multicenter P1101MF Study (NCT04988815) evaluating ropeginterferon alfa-2b in patients with early/pre-fibrotic primary myelofibrosis (pre-PMF) and a Dynamic International Prognostic Scoring System (DIPSS) score of low/intermediate-1 risk of MF is ongoing. 64 , 65 Participants receive ropeginterferon alfa-2b at a starting dose of 250 µg, followed by 350 µg at week 2, 500 µg at week 4, and 500 µg every 2 weeks thereafter. 64 As of the 27 February 2023 data cut-off, 62 patients had enrolled; 71% (44/62) had pre-PMF, 9.7% (6/62) had overt PMF, 8.1% (5/62) had post-PV MF, and 11.3% (7/62) had post-ET MF.…”

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

“… 64 , 65 Participants receive ropeginterferon alfa-2b at a starting dose of 250 µg, followed by 350 µg at week 2, 500 µg at week 4, and 500 µg every 2 weeks thereafter. 64 As of the 27 February 2023 data cut-off, 62 patients had enrolled; 71% (44/62) had pre-PMF, 9.7% (6/62) had overt PMF, 8.1% (5/62) had post-PV MF, and 11.3% (7/62) had post-ET MF. 65 Clinicohematologic CR in patients at 12 weeks ( n = 46) and 24 weeks ( n = 30) was 74% and 67%, respectively.…”

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

“… 64 As of the 27 February 2023 data cut-off, 62 patients had enrolled; 71% (44/62) had pre-PMF, 9.7% (6/62) had overt PMF, 8.1% (5/62) had post-PV MF, and 11.3% (7/62) had post-ET MF. 65 Clinicohematologic CR in patients at 12 weeks ( n = 46) and 24 weeks ( n = 30) was 74% and 67%, respectively. 64 Responses in hemoglobin (defined as 10 g/dL to upper limit of normal), WBC (defined as WBC < 10 × 10 9 /L), and platelet (defined as platelet count ⩽400 × 10 9 /L) at 24 weeks were achieved in 76.6%, 87.2%, and 78.7% of patients, respectively.…”

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

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Interferons in the treatment of myeloproliferative neoplasms

Vachhani,

Mascarenhas,

Bose

et al. 2024

Therapeutic Advances in Hematology

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Interferons are cytokines with immunomodulatory properties and disease-modifying effects that have been used to treat myeloproliferative neoplasms (MPNs) for more than 35 years. The initial use of interferons was limited due to difficulties with administration and a significant toxicity profile. Many of these shortcomings were addressed by covalently binding polyethylene glycol to the interferon structure, which increases the stability, prolongs activity, and reduces immunogenicity of the molecule. In the current therapeutic landscape, pegylated interferons are recommended for use in the treatment of polycythemia vera, essential thrombocythemia, and primary myelofibrosis. We review recent efficacy, molecular response, and safety data for the two available pegylated interferons, peginterferon alfa-2a (Pegasys) and ropeginterferon alfa-2b-njft (BESREMi). The practical management of interferon-based therapies is discussed, along with our opinions on whether to and how to switch from hydroxyurea to one of these therapies. Key topics and questions related to use of interferons, such as their safety and tolerability, the significance of variant allele frequency, advantages of early treatment, and what the future of interferon therapy may look like, will be examined. Pegylated interferons represent an important therapeutic option for patients with MPNs; however, more research is still required to further refine interferon therapy.

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Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 94%

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

Section: Efficacy/safety Of Interferons In Clinical Trialsmentioning

confidence: 99%

See 2 more Smart Citations

Interferons in the treatment of myeloproliferative neoplasms

Vachhani,

Mascarenhas,

Bose

et al. 2024

Therapeutic Advances in Hematology

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“…Ropeginterferon, discussed further in the PV and ET discussions later, is being studied in prefibrotic MF and lower risk‐overt MF, with promising control of blood counts as well as reduction in JAK2 V6 17F allele burdens. In a phase 2 trial with a median follow‐up of 55 weeks, 92% of 39 evaluated patients with JAK2 V6 17F mutation exhibited stable or improved allele burdens on ropeginterferon 34 …”

Section: Advances In Myelofibrosismentioning

confidence: 99%

Top advances of the year: Myeloproliferative neoplasms

Bhave,

Mesa,

Grunwald

2023

Cancer

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The rapid pace of drug development in hematology has led to multiple approvals for myelofibrosis (MF) and polycythemia vera (PV) in recent years. Moreover, there are many innovative agents and combinations being explored for myeloproliferative neoplasms (MPNs). In the past year, there have been several advances in MF, PV, and essential thrombocythemia. In MF, investigational approaches are focusing on strategies to optimize inhibition of signal transduction (including JAK inhibition), modify epigenetics, enhance apoptosis, target DNA replication, transform host immunity, and/or alter the tumor microenvironment. In PV, ropeginterferon alfa‐2b has been introduced to the market in the United States, and data continue to accumulate to support the safety and efficacy of this treatment. Hepcidin mimesis is also emerging as a novel way to treat erythrocytosis. In essential thrombocythemia, ropeginterferon alfa‐2b is being evaluated, as are therapies to modify epigenetics and inhibit CALR. The enhanced focus on MPNs brings hope that our field can improve morbidity and mortality in this group of diseases.

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Evolving landscape of JAK inhibition in myelofibrosis: monotherapy and combinations

Gill,

Leung,

Kwong

2023

Hematology

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Myeloproliferative neoplasms (MPNs) are characterized by clonal myeloproliferation in 1 or more of the hematopoietic stem cell lineages. Primary myelofibrosis (MF), post–polycythemia vera MF, and post–essential thrombocythemia MF have the worst prognosis and are characterized by the presence of cytokine-mediated symptom complex, splenomegaly, progressive marrow failure, and clonal instability, leading to leukemic transformation. The key therapeutic aims encompass the management of symptoms, splenomegaly, and anemia and the improvement of survivals. These therapeutic aims have evolved with the availability of Jak inhibitors and novel agents, making disease modification potentially achievable. Novel agents may potentially target MPN stem cells, epigenetic alterations, signaling pathways, and apoptotic pathways. In this case-based review, we outline our approach to the management of MF and discuss the therapeutic landscape of MF, highlighting the utility of Jak inhibitors and novel Jak inhibitor–based combinations.

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Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-Fibrotic Primary Myelofibrosis and DIPSS Low/Intermediate-1 Risk Myelofibrosis

Cited by 3 publications

References 0 publications

Interferons in the treatment of myeloproliferative neoplasms

Interferons in the treatment of myeloproliferative neoplasms

Top advances of the year: Myeloproliferative neoplasms

Evolving landscape of JAK inhibition in myelofibrosis: monotherapy and combinations

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