PharmaEssentia's Besremi (ropeginterferon alfa-2b), a treatment for polycythemia vera (PV), showcased exceptional therapeutic efficacy, achieving complete hematologic and molecular biologic responses in Korean patients who did not respond to hydroxyurea therapy, a study showed. 

Professor Lee Sung-eun of the Department of Hematology at Seoul St. Mary's Hospital presented the results of an investigator-initiated clinical trial of Besremi in Korean patients with PV at the American Society of Hematology's annual meeting (ASH 2023) held from Dec. 9-12 in San Diego, California, the U.S. 

PV, a rare blood cancer, results from mutated genes in blood-producing stem cells in the bone marrow, leading to a chronic overproduction of red blood cells, white blood cells, and platelets.

Besremi, a third-generation mono-pegylated interferon, selectively eliminates mutated cells in the bone marrow responsible for disease progression in PV. 

It is emerging as a promising treatment alternative for patients who have not responded to hydroxyurea, the current standard treatment for PV.

The study, an investigator-initiated clinical trial at the Myeloproliferative Tumor Research Institute affiliated with the Korean Society of Hematology, analyzed the complete hematologic and molecular biologic responses after receiving Besremi in 99 Korean patients with PV who had failed hydroxyurea treatment. 

The patients began treatment with Besremi at a dose of 250 mcg, increased to 350 mcg at week 2 and 500 mcg at week 4, and continued treatment through week 48. 

The results showed that 63 percent of patients on Besremi achieved a complete hematologic response and 57 percent achieved a molecular biologic response at 12 months, demonstrating sustained treatment efficacy. 

The safety profile of Vesremi was consistent with previously reported adverse events.

"This study demonstrates that early and rapid dose optimization of Besremi can lead to high hematologic and molecular biologic responses," Professor Lee said. 

“It also proved that hematologic and molecular biologic responses are correlated."

Also presented at ASH 2023 were results from a 72-month analysis of low-risk patients in a European multi-country phase 3 PROUD/CONTINUATION study of Besremi.

In the study, patients commenced at a dose of 100 mcg and were subsequently titrated up to 50 mcg every two weeks, individualized based on patient response. The maximum dose administered was 500 mcg every 2 weeks, and patients had the option to extend the dosing interval every 4 weeks until achieving a complete hematologic response or up to 1.5 years after initiation.

Besremi achieved complete hematologic responses of 80.4 percent and 73.2 percent at 24 and 72 months, respectively, demonstrating that Besremi dosing intervals and dosage can be optimized for each patient, allowing for personalized treatment.

"The investigator-initiated clinical trial presented at ASH 2023 holds significant importance as it could offer a treatment opportunity for Korean patients with PV who have lacked alternatives since the failure of hydroxyurea therapy in the past year," said Kim Ki-won, medical director of PharmaEssentia Korea.

"We will continue to do our best to ensure that Besremi is included in the Korean health insurance program so that patients who have failed hydroxyurea therapy can enjoy a new treatment opportunity."