Presentations highlight two-year Phase 3 data and real-world evidence for BESREMi® (ropeginterferon alfa-2b) in essential thrombocythemia (ET)
BESREMi was recently FDA-approved for the treatment of adults with ET, regardless of genotype or disease status
BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced two poster presentations at the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting, which will be held September 9-12 in Houston, Texas.
PharmaEssentia will present two-year results from the Phase 3 SURPASS-ET study (NCT04285086) and its ongoing extension in adults with high-risk essential thrombocythemia (ET) who were resistant to or intolerant of hydroxyurea. In the extension, it was observed that study participants who continued BESREMi® (ropeginterferon alfa-2b-njft) maintained modified ELN response rates and platelet and white blood cell control through two years, with continued reduction in JAK2V617F variant allele burden and a safety profile consistent with prior reports. Patients followed in the extension study who transitioned from anagrelide to BESREMi after the 52-week core study showed improved hematologic control and reduced JAK2V617F allele burden relative to their prior anagrelide therapy. Long-term efficacy and safety analyses are ongoing. Two-year results were presented in part as an oral presentation at the European Hematology Association (EHA) 2026 Congress.
Additionally, PharmaEssentia will present real-world evidence from a retrospective cohort study of 55 patients with ET evaluating the use of BESREMi in community oncology settings. The analysis found that BESREMi was most commonly initiated after first-line therapy, while first-line use was also observed, predominantly in younger patients. Platelet counts and response rates trended toward optimal levels regardless of prior cytoreductive therapy history.
Poster Presentation Details
Title: Efficacy and Molecular Dynamics of Ropeginterferon Alfa-2b in High-risk Essential Thrombocythemia: Two-year Results from the Phase 3 SURPASS-ET Trial
Abstract Number: 944
Poster Number: MPN-944
Presenter: Dr. Lucia Masarova, University of Texas MD Anderson Cancer Center
Date: 9/9/26
Time: 6:25-7:55 PM
Title: Real-world Patient Characteristics, Treatment Patterns and Blood Counts of Patients with Essential Thrombocythemia Treated with Ropeginterferon Alfa-2b in the US Community Oncology Setting
Abstract Number: 1090
Poster Number: MPN-1090
Presenter: Dr. Solly Chedid, Singing River Cancer Center
Date: 9/9/26
Time: 6:25-7:55 PM
About PharmaEssentia
PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).
About Essential Thrombocythemia (ET)
Essential thrombocythemia (ET) is a rare blood disorder and type of myeloproliferative neoplasm (MPN). It is characterized by the bone marrow overproducing platelets. Patients with ET are at an increased risk of blood clots, abnormal bleeding and enlarged spleens. ET is often caused by genetic mutations such as a JAK2 genetic mutation.
About BESREMi® (ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV) and essential thrombocythemia (ET).
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera and essential thrombocythemia in adults. The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.
INDICATION
BESREMi® is indicated for the treatment of adults with polycythemia vera and for the treatment of adults with essential thrombocythemia.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders.
CONTRAINDICATIONS
Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt
- Hypersensitivity to interferons or to any of the inactive ingredients in BESREMi
- Hepatic impairment (Child-Pugh B or C)
- History or presence of active serious or untreated autoimmune disease
- Immunosuppressed transplant recipients
WARNINGS AND PRECAUTIONS
- Depression and Suicide: Monitor for symptoms and need for treatment.
- Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed.
- Cardiovascular Toxicity: Avoid use in patients with severe or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently.
- Hematologic and Hemorrhagic Disorders: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment.
- Hypersensitivity Reactions: Stop treatment and immediately manage reaction.
- Pancreatitis: Consider discontinuation if confirmed pancreatitis.
- Colitis: Discontinue if signs or symptoms of colitis.
- Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment.
- Ophthalmologic Toxicity: Monitor for ocular toxicity. Promptly evaluate eye symptoms and discontinue if new or worsening eye disorders.
- Hyperlipidemia: Monitor serum triglycerides before BESREMi treatment and intermittently during therapy and manage when elevated.
- Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity.
- Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops.
- Dental and Periodontal Toxicity: Advise on good oral hygiene and regular dental examinations.
- Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity.
- Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination.
- Embryo-Fetal Toxicity: Can cause fetal harm.
Please see full Prescribing Information, including Boxed Warning.
Contacts
Media Contact
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com
