Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Key claim: This phase 3 trial tests whether bomedemstat is superior to hydroxyurea in achieving durable clinicohematologic response in cytoreductive therapy-naïve essential thrombocythemia patients.
Abstract
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.
Why this matters
Hydroxyurea has been the default frontline cytoreductive therapy for high-risk ET for decades, with interferon and anagrelide largely positioned in second-line or HU-intolerant settings. A phase 3 superiority trial of bomedemstat — a mechanistically novel LSD1 inhibitor — directly versus HU in treatment-naïve ET is the first attempt to displace HU as the ET standard of care, and would reshape the frontline algorithm for this subtype if positive. It also complements the parallel ET frontline shift signaled by ropeginterferon’s SURPASS-ET data and NCCN category 1 upgrade.