‘Aggressive interferon treatment needed to reach MRD in myeloproliferative neoplasms’

PharmaEssentia Korea said it hosted a myeloproliferative neoplasms (MPN) forum to share the latest insights on Besremi (ropeginterferon alfa-2b), a treatment for polycythemia vera (PV) on Thursday last week.

The forum featured two world-renowned experts in the field of MPN -- Professor Hans Carl Hasselbach of the Department of Hematology at Zealand University Hospital, Denmark, and Professor Jean-Jacques Kiladjian at Paris City University, France -- who discussed key clinical studies of Besremi in Korea and abroad, as well as the outlook for the treatment landscape for PV.

In the first session, Professor Hasselbach spoke about the importance of early interferon treatment.

"MPN is an inflammatory disease, and an increase in JAK2 mutant cells in bone marrow cells increases the risk of cardiovascular events, such as thrombosis and cerebral infarction, bone marrow fibrosis, and secondary cancers," Professor Hasselbach said. "To prevent progression of MPN, early and aggressive treatment with interferons that act directly on bone marrow cells is essential to achieve a microscopic residual disease (MRD) status."

In the second session, Professor Kiladjian, who led Besremi's licensed PROUD/CONTINUATION trial, presented the results of a cohort study on the potential for interferon treatment discontinuation.

"We studied the feasibility of interferon discontinuation in 469 patients with myeloproliferative neoplasms and found that the majority of patients who maintained a hematologic response on interferon treatment for more than two years and had less than 10 percent JAK2 mutant cells did not relapse for more than 10 years after interferon discontinuation," Professor Kiladjian said.

Kiladjian added that Besremi has demonstrated that selective elimination of JAK2-mutant cells not only improves event-free survival compared to hydroxyurea but also prevents disease progression with long-term treatment.

The final session was titled "Treatment Paradigm Shifts and Issues in Myeloproliferative Neoplasms Due to the Emergence of New Treatment Options."

It featured a panel discussion with Korean experts in myeloproliferative neoplasms, including Professor Kim Sung-yong of the Department of Oncology and Hematology at Konkuk University Medical Center, Professor Lee Sung-eun of the Department of Hematology at the Catholic University of Korea Seoul St. Mary's Hospital, Professor Won Jong-ho of the Department of Oncology and Hematology at Soon Chun Hyang University Hospital Seoul, and Professor Jung Chul-won of the Department of Hematology and Oncology at Samsung Medical Center.

In the session, Professor Kiladjian said, "As molecular response, which is the reduction of JAK2 mutations, is proving to be a surrogate marker for disease progression and prolonged survival, the goal of MPN treatment is expected to shift to achieving molecular response. However, the effectiveness of therapeutic agents is still primarily evaluated by hematologic response."

Professor Hasselbach said, "Besemi is a new drug for PV that can be treated intermittently in patients whose hematologic levels stabilize with long-term treatment. This allows for patient-specific treatment and is cost-effective, as it can be discontinued when a certain level of hematologic response is reached after more than three years of treatment."

In February, the National Assembly's Health and Welfare Committee referred Besremi after 50,000 people signed a petition to cover it with health insurance. PharmaEssentia Korea submitted a drug decision application to the Health Insurance Review and Assessment Service for health insurance review in March.