Selected plenary presentation highlights positive Phase 3 SURPASS-ET clinical trial results of ropeginterferon alfa-2b-njft for the treatment of essential thrombocythemia (ET)
Additional oral presentation to showcase Phase 2 data in pre-fibrotic primary myelofibrosis (PMF)
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 it will be presenting clinical study results at the 2025 European Hematology Association (EHA) Congress, taking place June 12-15 in Milan, Italy.
The company’s results from the Phase 3 SURPASS-ET trial (NCT04285086) have been selected for an oral presentation during the plenary session—one of six top-ranked abstracts chosen by the EHA 2025 Scientific Program Committee. The presentation, led by Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong, will share data from the Phase 3 SURPASS-ET study demonstrating the efficacy and safety of ropeginterferon alfa-2b versus anagrelide in essential thrombocythemia (ET).
Earlier this year, PharmaEssentia announced positive topline SURPASS-ET Phase 3 results, with ropeginterferon alfa-2b-njft demonstrating a significantly higher durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001), along with a favorable safety profile and a greater reduction in JAK2 V617F allelic burden over 12 months.
“I’m deeply honored that the SURPASS-ET study results were selected for a plenary presentation at the EHA Congress. This recognition underscores the significance of the data for patients living with ET,” said Dr. Harry Gill, hematologist and oncologist at the University of Hong Kong. “The SURPASS-ET data offer compelling evidence that ropeginterferon alfa-2b could provide a much-needed new treatment option for the ET community.”
In addition to the plenary presentation, Dr. Gill will also present results from the University of Hong Kong’s Phase 2 trial (NCT05731245) evaluating ropeginterferon alfa-2b in pre-fibrotic primary myelofibrosis (PMF) and DIPSS low/intermediate-risk myelofibrosis during an oral session focused on innovative treatment approaches in myeloproliferative neoplasms (MPNs).
“Ropeginterferon alfa-2b has already reshaped the treatment landscape for polycythemia vera, and the growing body of evidence in ET and pre-fibrotic PMF points to its broader potential across the spectrum of MPNs,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia USA. “We’re proud to advance innovative science that may offer patients with an alternative treatment option.”
Presentation Details
- Abstract Code: S102
- Title: Better safety and efficacy with ropeginterferon alfa-2b over anagrelide as second-line treatment of essential thrombocythemia in the topline results of the randomized Phase 3 SURPASS-ET trial
- Session: Plenary Abstracts
- Date/Time: June 14, 11:45-13:15 CEST
- Abstract Code: S222
- Title: Ropeginterferon alfa-2b for pre-fibrotic primary myelofibrosis and DIPSS low/intermediate-risk myelofibrosis
- Session: Innovative treatment approaches in MPN
- Date/Time: June 12, 17:00–18:15 CEST
About Essential Thrombocythemia
Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism.
About BESREMi® (ropeginterferon alfa-2b-njft) in Polycythemia Vera (PV)
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). BESREMi® has been recognized by the National Comprehensive Cancer Network® (NCCN®) as a preferred first-line cytoreductive therapy for adults with symptomatic, low-risk PV and the only preferred therapeutic option for both high-risk and low-risk (symptomatic) patients, regardless of treatment history. The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and anticipates submitting a BLA with the U.S. FDA.
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia and is manufactured at the company’s facility in Taichung. PharmaEssentia retains full global intellectual property rights across all indications.
BESREMi® was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.
Please see full Prescribing Information, including Boxed Warning.
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).
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Contacts
Media
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com
