Interesting

[wateron]

Clinical Review of ropeginterferon alfa-2b Suggests Amended Dosing Schedule May Support Improved Clinical Outcomes in Polycythemia Vera

Review of studies published in Frontiers in Oncology highlights dosing considerations that may help more patients achieve earlier complete hematological response

February 02, 2023 08:00 AM Eastern Standard Time

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 the publication of a review of clinical literature in the journal, Frontiers in Oncology. The research indicates that an amended dosing schedule, with higher initial dose and faster dose titration of ropeginterferon alfa-2b (marketed as BESREMi®), may correlate to earlier complete hematological response (CHR) in polycythemia vera (PV) in adults. The analysis titled, “An alternative dosing strategy for ropeginterferon alfa-2b may help improve outcomes in myeloproliferative neoplasms: An overview of previous and ongoing studies with perspectives on the future,” was co-authored by PharmaEssentia researchers.

“As more clinicians gain familiarity with BESREMi®, we want to support treatment goals by ensuring patients can effectively achieve and maintain their target clinical and molecular responses, as this may help reduce the risk of disease progression over time”

“This publication delves into the critical connection between an accelerated dosing regimen for ropeginterferon alfa-2b and the key efficacy, safety and tolerability outcomes we aim to achieve for our patients,” said John Mascarenhas, M.D., Director of the Adult Leukemia Program and Leader of Clinical Investigation within the Myeloproliferative Disorders Program at Mount Sinai and study author. “The data from these clinical and investigational studies suggest that a higher starting dose and faster titration could be an appropriate approach to attain clinical outcomes earlier while minimizing the risk of thrombosis and hemorrhage in patients with PV.”

PV is the most common myeloproliferative neoplasm (MPN) and a long-term, potentially life-threatening disease with limited treatment options. Recent clinical investigations suggest the potential for rapid titration and higher starting doses to benefit those with PV.1

The publication highlights the findings from multiple studies supporting the efficacy, safety and tolerability of a 250-350-500 mcg titration dosing regimen of ropeginterferon alfa-2b:

A compassionate use program (CUP) study in Taiwan (n=14; hydroxyurea and/or anagrelide resistance or intolerance patients) resulted in a CHR rate of 73% at 52 weeks vs 51% observed in a study with a slower titration method. No new safety signals were detected.

Interim results from an ongoing, Phase 2, single-arm study in Chinese PV patients (n=49; resistant or intolerant to hydroxyurea) showed that amended dosing achieved a CHR rate of 52% at Week 24 compared to 43% at Week 52 observed in PROUD-PV. Treatment-related Grade >3 adverse events (AEs) were reported in five patients (10.2%).

Data from an investigator-initiated trial in Korea (n=45; hydroxyurea naïve or pre-treated PV patients) indicated higher hematologic and molecular responses at 6 months. Dose reductions were required in 4.4% of patients and the majority of AEs were Grade 1 or 2 with no treatment-related serious AEs reported.

Across the studies, ropeginterferon alfa-2b was generally well-tolerated. No thromboembolic complications have been reported with the accelerated titration regimen in PV. Rather, the review authors indicate that it is reasonable to believe that the accelerated dosing regimen may potentially minimize the risk of thrombosis and hemorrhage associated with an under-dosing during dose titrations.

“As more clinicians gain familiarity with BESREMi®, we want to support treatment goals by ensuring patients can effectively achieve and maintain their target clinical and molecular responses, as this may help reduce the risk of disease progression over time,” said Raymond Urbanski, M.D., Ph.D., Senior Vice President and U.S. Head of Clinical Development and Medical Affairs. “This latest research will help support more informed dialogue among physicians regarding their patients with PV.”

PharmaEssentia is interested in the attributes of the amended dosing approach with ropeginterferon alfa-2b that may extend into related MPNs with unmet needs such as essential thrombocythemia (ET) and pre-fibrotic primary myelofibrosis (pMF). Several planned or ongoing Phase 3 clinical trials will further evaluate this regimen of ropeginterferon alfa-2b in ET (SURPASS and EXCEED trials) and PV (ECLIPSE trial). Plans for a Phase 3 clinical trial in pMF are also underway.

[hunter5582]

Just reviewed the same article. Very interesting. Thanks for posting it.

[Ovidess]

My hema/oncologist said, when I sent him this info, that he didn't think insurance would approve this sped up sequencing of Besremi. Not yet. So I am creeping my way upwards by 50 mcg every two weeks. No action on the red blood cell or platelet count yet, as I'm just reaching 200 this week. I have to pretend, for now, that this is someone else's suspense story.

[KLCTJC in reply to Ovidess]

According to Dr V at MDA this is a slow acting drug. I know what this article says, but I still wonder if some people have to reduce dosing long term. Dr V liked the idea of once you reach 150 or higher to go up by 50 once a month. I think Besremi takes time. He warned me it may take a year. It makes sense titrations higher faster gets quicker results but like I said makes me question long term. I know next week I will see no improvement after 2 doses. But the article is interesting. I am going to bring it with me next week when I see my local oncologist but may still go with next increase and give it a month. Will see! Just glad to see so much positivity around this medication! Thanks for the information

[mfh7 in reply to KLCTJC]

For what it is worth I am also a patient of Dr V and am now at the max dose of 500 mcgs after slow increases over a one year period. Most of my numbers have improved, especially platelets, but still requiring phlebotomy approximately once every two months to keep hct below 45. Hoping increased dosage will eventually slow or stop the rate at which my hct increases above 45. Even if it does not, I feel the benefits to my other counts and the possibility of decreased allele burden justify continued use of besremi absent any side effects which so far has have had very little. Unfortunately Dr V is retiring so I am being assigned to a different doc at MDA. Wondering if you have heard the same. Best of luck!

[KLCTJC in reply to mfh7]

Yes, so sad! I saw him the end of January and he told me. They have reassigned me to a Dr. Will have to look her up. He said she is taking all the interferon patients. I will go back in 6mos. Glad to hear that about your labs as my issue is not my hct. I only need phlebotomy every 5-6 mos. I need platelet and wbcs. Here is hoping it works for me!

[Bluetop]

Interesting. Thanks fo posting.

[Scottishterrier]

Hi i have been on it since having a hepatic infarction many years ago and have had no problems that can't be dealt with I am domperidone for the nausea and I do get tired very easy but it really has my platelets under control really well I am down to one on a Monday which can be an off day my hairloss was non existent I would not take any else I have et jak2+Stay safe

Scottish terrier

[gvibes]

Thanks for sharing paper. This isn’t very scientific but I noticed while taking pegasys, that raising the dose for a few weeks seemed to get it going as far as lowering red blood cells. Afterwards a lower dose was more effective than before. It was like the short term higher dose was a trigger. Maybe this is a similar effect.