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Increased Besremi Dose to Be Studied for Polycythemia Vera Treatment

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A clinical trial studying an accelerated dose of Besremi recently kicked off.

The first patient has been dosed in a phase 3b clinical trial examining Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with the myeloproliferative neoplasm, polycythemia vera, a type of blood cancer where the bone marrow makes too many too many red blood cells.

The ECLIPSE PV trial will evaluate an accelerated dosing schedule for Besremi and compare it with the dose that is currently approved for this patient population. The main goal of the trial is the proportion of patients who achieve a complete hematologic response, which is indicates that the blood cells are in the normal range (red blood cell volume of less than 45%) for three or more months. The timeframe of the trial is 24 weeks.

Researchers will also look at the cancer-fighting abilities, safety and tolerability for the two dosing regimens of Besremi.

The trial will involve approximately 100 patients with polycythemia vera. They will be randomly assigned to receive either the accelerated dose (starting at 250 mcg then increasing to 350 mcg at week 2, with a goal of getting to 500 mcg at week 4) or the currently approved dosing (50 or 100 mcg), according to a press release published by PharmaEssentia USA.

"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 Dr. Raymond Urbanski, U.S. head of clinical development and medical affairs at PharmaEssentia USA, in a press release. "We believe this study will deliver further insight into the potential of Besremi to meet the needs of PV patients."

Patients can speak to their health care providers about potential participation in the trial, which is currently recruiting participants.

To be eligible, patients must be 18 years or older, been diagnosed with polycythemia vera between 2008 and 2016 per the World Health Organization Criteria, have good liver function and pre-specified blood levels and be able to consent to the study. Patients who cannot receive interferon alfa, stopped interferon alfa or are hypersensitive to interfon alfa are not eligible. Patients must also not have a history of major organ transplant, be pregnant or breastfeeding or have any diseases that may conflict with the study.

Besremi was approved in November 2021 for patients with polycythemia vera based on clinical trial findings that showed that 61% of patients treated with the agent for 7.5 years experienced a complete hematological response.

In a March 2022 interview with CURE®, Dr. Naveen Pemmaraju, an associate professor in the department of leukemia at MD Anderson Cancer Center, said that Besremi’s approval is “one of the most important developments” in the treatment for polycythemia vera.

"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," Dr. John Mascarenhas, professor of medicine, hematology, and medical oncology at the Icahn School of Medicine at Mount Sinai in New York, said in the press release. "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."

Researchers predict that the ECLIPSE PV study will be completed in December 2025.

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