Single-arm trial will evaluate an accelerated dosing schedule
BURLINGTON, Mass.–(BUSINESS WIRE)– PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx: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 that the first patients are now being dosed in ECLIPSE PV, a Phase 3b clinical study evaluating an accelerated dosing schedule for ropeginterferon alfa-2b-njft using a prefilled syringe for the treatment of adults with polycythemia vera (PV).
Ropeginterferon alfa-2b-njft (marketed as BESREMi®) was approved by the U.S. Food and Drug Administration in November 2021 as a treatment for adults with PV.1 PV is a rare, chronic and life-threatening blood cancer caused by a mutation in hematopoietic stem cells in the bone marrow, resulting in the overproduction of red blood cells, white blood cells and platelets. Individuals with PV are at risk for serious health problems, including blood clots, stroke and heart attack.2,3 Without proper management, this debilitating cancer can progress into myelofibrosis and other malignancies, including acute myeloid leukemia.4
“This therapy represents an important addition to the treatment arsenal for PV in the U.S., and clinical data supports its use across a broad range of patients regardless of their treatment history,” said John Mascarenhas, M.D., professor of medicine, hematology, and medical oncology at the Icahn School of Medicine at Mount Sinai in New York. “This new study is addressing an important therapeutic and clinical question regarding whether treatment utilizing accelerated dosing leads to a more rapid hematologic and molecular response, indicating potential disease modifying activity and long-term disease control.”
The study will evaluate an accelerated dosing schedule for ropeginterferon alfa-2b-njft compared to the current labeled dosing. The primary endpoint is the proportion of patients achieving a CHR, defined as hematocrit <45% for at least 3 months since last phlebotomy, platelets ≤ 400 x 109/L, leukocytes ≤10 x 109/L, at 24 weeks of treatment. Approximately 100 adults with PV in the U.S. and Canada will be randomized to receive either the accelerated dosing (i.e., starting dose of 250 mcg, then 350 mcg at week 2, with a target optimal dose of 500 mcg at week 4, and then dosing will remain fixed at the highest tolerated dose for the remainder of the treatment period) or patients will receive the current labeled dosing (50 or 100 mcg starting dose with 50 mcg titration every 2 weeks). There is a 48-week study period followed by a 28-day safety follow-up. Those who respond to treatment will be eligible to participate in a long-term extension phase of the study.
“Our goal with this study is to deliver evidence on the potentially enhanced benefits of treating patients with BESREMi through this accelerated dosing schedule and to bring additional confidence to clinicians and patients in the utility of the treatment to manage this chronic cancer,” said Raymond Urbanski, M.D., Ph.D., U.S. Head of Clinical Development and Medical Affairs. “We believe this study will deliver further insight into the potential of BESREMi to meet the needs of PV patients.”
More information on the study including eligibility criteria can be found by visiting www.eclipsepv.com or www.clinicaltrials.gov and searching for the trial identifier NCT05481151. Topline data from the trial are expected by 2024.