NOTE

🌱 created from: fedratinib

freedom2

Efficacy and Safety of Fedratinib in Patients with Myelofibrosis Previously Treated with Ruxolitinib: Results from the Phase 3 Randomized FREEDOM2 Study

TLDR: 對大 spleen 的減少和症狀反應率比 Best Available Therapy 好

1. Design:

   • Phase 3
   • Open-label, randomized
   • Multi-center

2. Number of Patients:

   • 201 patients initially randomized and treated
   • 134 patients in the FEDR arm
   • 67 patients in the BAT arm

3. Patients Characteristics:

   • Median age: 70 years
   • 52.2% male
   • Majority had primary MF and intermediate-2 DIPSS risk

4. Agent:

   • FEDR (Fedratinib) 400 mg/day
   • Best Available Therapy (BAT) with mostly RUX, hydroxyurea, or RUX plus hydroxyurea in the BAT arm

5. Treatment Line:

   • Patients previously treated with RUX

6. Trial Acronym or NCTId Number:

   • FREEDOM2 (NCT03952039)

7. Compare Efficacy:

Parameter	Result
SVR35 at EOC6	FEDR: 35.8%, BAT: 6.0%

8. Highlight of Toxicity:

   • Diarrhea (38.1% FEDR)
   • Nausea (32.1% FEDR)
   • Thrombocytopenia (11.9% FEDR)
   • Anemia (9.0% FEDR)
   • Thiamine deficiency (16.4% FEDR)

9. One-Line Summary:

   • In a phase 3 study, Fedratinib showed superior spleen volume reduction and symptom response rates compared to Best Available Therapy in patients with MF and prior RUX treatment, with manageable side effects.