Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)

In July 2024, Active Biotech entered into a clinical trial agreement with MD Anderson Cancer Center, TX, US, to start a clinical phase II trial in patients with myelofibrosis. Thrombocytosis Myelofibrosis (Post-ET MF)”. The study is actively enrolling patients since August 2024.

The title of the study is: “Open Label Phase 2 Study of Tasquinimod in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential The study is composed of two separate cohorts which recruit patients parallelly. Cohort 1 evaluates tasquinimod as a single agent in patients with JAKi refractory disease and in patients who are ineligible for JAKi treatment. Cohort 2 evaluates tasquinimod in combination with the JAKi in patients who have a suboptimal response to JAKi alone. The study will enroll up to 33 patients: 12 in cohort 1 and 21 in cohort 2.

The primary endpoint for both cohorts is efficacy: Objective Response Rate (ORR) according to the International Working Group (IWG-MRT) criteria for treatment response in myelofibrosis. ORR is defined as the proportion of patients with Complete Remission (CR), Partial Response (PR) or Clinical Improvement (CI) after six cycles of treatment. Secondary endpoints include safety and tolerability, time to response, response duration, changes in spleen volume and symptom score as well as bone marrow fibrosis grade.

The study is carried out in an academic partnership with MD Anderson Cancer Center, TX, US with Dr Lucia Masarova as the Principal Investigator. More information about the study available at clinicaltrials.gov (NCT06327100).