Clinical Trial

Title: A Phase 2/3, randomized, open-label, active-comparator-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of bomedemstat(MK-3543) versus best available therapy in participants with polycythemia vera who have an inadequate response to or are intolerant to hydroxyurea (MK-3543-025)

MOA: Bomedemstat (MK-3543) is an irreversible inhibitor of LSD1.

Key Eligibility:

• Subjects must have a confirmed local diagnosis of PV per WHO criteria
• Discontinued prior cytoreductive therapy for ≥5 half-lives before study
  treatment (phlebotomy permitted) and failed at least one prior cytoreductive
  therapy used to lower hematocrit
• Subjects must have a history of inadequate response, resistance to, or
  intolerant to HU per at least one of the protocol-specified criteria, based on
  modified ELN criteria for HU resistance or intolerance
• Locally assessed BM fibrosis Grade 0-1; must provide archival (≤6 months
  old) or newly obtained BM biopsy sample for central review.
• No splenomegaly or related symptoms; spleen size normal on exam or
  imaging (≤13 cm)
• Subjects currently receiving anticancer therapy are excluded
• Subjects that received bomedemstat in the past are excluded