November 24, 2025 — Leads & Copy — PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), has announced the publication of positive results from its pivotal Phase 3 SURPASS-ET clinical trial in The Lancet Haematology. The trial (NCT04285086) assessed the efficacy of ropeginterferon alfa-2b-njft in patients with essential thrombocythemia (ET).
The published paper, titled “Ropeginterferon alfa-2b in hydroxyurea-intolerant or hydroxyurea-refractory essential thrombocythaemia (SURPASS ET): a multicentre, open-label, randomised, active-controlled, phase 3 study,” highlights the potential of ropeginterferon alfa-2b-njft as a new therapeutic option for patients with essential thrombocythemia (ET), a chronic myeloproliferative neoplasm (MPN) characterized by uncontrolled platelet production and an elevated risk of blood clots and progression to more serious cancers.
The study compared ropeginterferon alfa-2b with anagrelide in ET patients with leukocytosis who were resistant or intolerant to hydroxyurea. The results showed that 43% of patients receiving ropeginterferon alfa-2b achieved durable responses at months 9 and 12, compared to 6% of those receiving anagrelide. These responses were defined by modified ELN criteria.
Ropeginterferon alfa-2b also demonstrated more robust hematologic responses, greater symptom improvement, improved control of splenomegaly, fewer thromboembolic events and deeper molecular responses across key patient subgroups. Treatment with ropeginterferon alfa-2b resulted in significant reductions in JAK2 V617F allele burden, an indicator of potential disease-modifying activity in MPNs. The therapy was well tolerated, with no major cardiac or neurological events and lower rates of significant adverse events and treatment discontinuations relative to anagrelide.
Ruben Mesa, MD, lead author of the publication and President of Advocate Health’s Cancer National Service Line, said the SURPASS-ET data are impressive and demonstrate durable clinical and symptomatic benefits with ropeginterferon alfa-2b, along with reductions in JAK2 V617F allele burden. Mesa added that after nearly three decades without new therapeutic options, these findings represent a promising step forward for patients and clinicians.
Ko-Chung Lin, PhD, Founder and Chief Executive Officer of PharmaEssentia, said the findings reinforce the therapy’s potential to benefit patients across the MPN spectrum. Lin added that the company looks forward to advancing regulatory efforts to bring this therapy to individuals living with ET, supporting the potential to expand commercialization efforts in this new indication in 2026, pending FDA approval.
PharmaEssentia USA Corporation is a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan. PharmaEssentia aims to deliver effective new biologics for challenging diseases in hematology, oncology, and immunology.
Essential thrombocythemia is a rare blood disorder characterized by the bone marrow overproducing platelets, increasing the risk of blood clots, abnormal bleeding, and enlarged spleens. Genetic mutations such as a JAK2 genetic mutation, can cause ET.
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults and has received regulatory approval in over 40 countries, including the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023).
Please see full Prescribing Information, including Boxed Warning. Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide, Endocrine Toxicity, Cardiovascular Toxicity, Decreased Peripheral Blood Counts, Hypersensitivity Reactions, Pancreatitis, Colitis, Pulmonary Toxicity, Ophthalmologic Toxicity, Hyperlipidemia, Hepatotoxicity, Renal Toxicity, Dental and Periodontal Toxicity, Dermatologic Toxicity, Driving and Operating Machinery.
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Source: PharmaEssentia
