Two Year Results from the First Prospective Randomized Controlled Trial
Third in ASH 2017 Series
by David Wallace
Dr Jean Jacques Kiladjian, Professor of Clinical Hematology, Hopital Saint-Louis, Paris, France interviews with David Wallace, PV Reporter at ASH 2017. Discussing Ropeginterferon Alfa-2b Induces High Rates of Clinical, Hematological and Molecular Responses in Polycythemia Vera – 2 year Results from the First Prospective Randomized Controlled Trial.
Summary of Key Points:
- Last year at 12 months showed equivalent results using Ropeginterferon (Ropeg) vs. Hydroxyurea (HU).
- At 2 year analysis, patients on Ropeg had a continuous increase in the rate of complete response compared to a loss of response at 2 years on HU treatment.
- Molecular response along with a continuous decrease in allele burden was seen in year 2.
- Interferon is a slow acting drug, better results were expected in the second year.
- Patients started with low dose Ropeg with a slow increase, achieved efficient dosage at 6 months (this is an improvement over Pegasys, which can take longer to find the proper dosage).
- AOP Orphan has licensing rights for Ropeg in Europe, EMA started the process in February 2017, waiting on 2 year results that were just released.
- They are hoping for approval in early 2018 and begin using Ropeg by the middle to end of 2018.
- The approval process in the U.S. through the FDA may be slower as they may ask for additional studies.