PHARMAESSENTIA CORPORATION
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Overall, these analyses indicate that patients with polycythemia vera (PV) treated with ropeginterferon alfa-2b (marketed as BESREMi ) had an increased probability of achieving complete hematologic response (CHR) and a molecular response with acceptable safety risks when using a 250-350-500 -microg dosing regimen. Writing and editorial support were funded by
Among key findings, patients with PV treated with ropeginterferon alfa-2b had an increased probability of achieving CHR and reducing JAK2V617F allele burden with acceptable safety risks. The exposure-safety population was comprised of 49 patients from the Phase 2 Chinese study (A20-202). In this study, of the high-frequency treatment-related adverse events (TRAEs), only increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed to be associated with average ropeginterferon alfa-2b exposure in the 500 -microg phase.
'Our exposure-efficacy modeling further demonstrates the effectiveness of ropeginterferon alfa-2b in achieving CHR and reducing the JAK2V617F allele burden for patients with PV,' said
More About this Analysis
In this study, exposure-response (E-R) analyses were performed to evaluate the efficacy and safety of the dosing regimens, based on the results of the Chinese A20-202 study evaluating subcutaneous ropeginterferon alfa-2b in patients with PV. The treatment protocol included a starting dose of 250 -microg at Week 0, followed by an intra-patient dose escalation to 350 -microg at Week 2 and then a target dose of 500 -microg at Week 4. The dose could be adjusted according to tolerability, and the maintenance dose was 500 g for up to 52 weeks if tolerated. The primary endpoint was the CHR rate at Week 24. Key secondary endpoints included the reduction of the JAK2V617F allele burden and safety. The safety variable was TRAEs.
The E-R analyses were based on logistic and linear regression and the relationship between exposure to ropeginterferon alfa-2b and key efficacy and safety variables. The population for the exposure efficacy analysis included 48 patients from the A20-202 trial who had both CHR and JAK2V617F allele burden measurements at Week 24.
The final exposure-CHR model structure for the A20-202 study demonstrated that ropeginterferon alfa-2b increases the probability of achieving CHR with its dose. The results derived from the E-R model indicated similar CHR probabilities within the third and fourth quantile range of the average concentration at Week 24.
About Polycythemia Vera (PV)
Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1
About BESREMi (ropeginterferon alfa-2b-njft)
BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients.
BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in
BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.
About
Forward Looking Statement
This press release may contain forward looking statements, including statements regarding the clinical benefits to be derived from ropeginterferon alfa-2b, the commercial opportunity and competitive positioning, new indications or labeling for ropeginterferon alfa-2b, and business prospects for ropeginterferon alfa-2b. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward looking statements as a result of various factors. These factors include whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Contact:
Email: murielhuang@pharmaessentia.com
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