BURLINGTON, Mass. — PharmaEssentia USA Corporation, a subsidiary of Taiwan-based PharmaEssentia Corporation (TWSE: 6446), announced that results from its pivotal Phase 3 SURPASS-ET clinical trial (NCT04285086) have been published in The Lancet Haematology.
The study, 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 treatment option for patients with essential thrombocythemia (ET). ET is a chronic myeloproliferative neoplasm marked by elevated platelet production and increased risks of clotting, bleeding and progression to more advanced cancers. There have been no new treatment approvals for ET in the United States since anagrelide in 1997.
SURPASS-ET compared ropeginterferon alfa-2b with anagrelide in patients with ET and leukocytosis who were resistant or intolerant to hydroxyurea. According to the findings, 43 percent of patients receiving ropeginterferon alfa-2b achieved durable clinical responses at months 9 and 12 under modified ELN criteria, compared with 6 percent of patients receiving anagrelide.
In addition to meeting its primary endpoint, the study reported greater hematologic responses, improved symptom control, reduced splenomegaly, fewer thromboembolic events and deeper molecular responses with ropeginterferon alfa-2b. Treatment also led to notable reductions in JAK2 V617F allele burden, a marker associated with possible disease-modifying activity. The therapy demonstrated a favorable safety profile with lower rates of significant adverse events and fewer treatment discontinuations than anagrelide, with no major cardiac or neurological complications reported.
“The SURPASS-ET data are impressive and demonstrate not only durable clinical and symptomatic benefits with ropeginterferon alfa-2b, but also reductions in JAK2 V617F allele burden—an important marker associated with potential disease modification,” said Ruben Mesa, M.D., lead author of the publication, principal investigator of the SURPASS-ET trial and President of Advocate Health’s Cancer National Service Line, which includes Atrium Health Levine Cancer Institute and the Comprehensive Cancer Center at Atrium Health Wake Forest Baptist. “ET remains a challenging chronic disease, and patients who are resistant or intolerant to hydroxyurea have had few alternatives for sustained disease control. After nearly three decades without new therapeutic options, these findings represent a promising step forward for patients and clinicians.”
“We are encouraged to see the SURPASS-ET results recognized in a leading peer-reviewed journal,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “Ropeginterferon alfa-2b-njft has already reshaped the treatment landscape for polycythemia vera, and the findings from this study further reinforce its potential to benefit patients across the MPN spectrum. We look forward to advancing our regulatory efforts to bring this therapy to individuals living with ET, supporting the potential to expand our commercialization efforts in this new indication in 2026, pending FDA approval.”
