Dr. Jean Jacques Kiladjian at ASH 2017 Ropeginterferon Induces High Rates of Clinical, Hematological and Molecular Responses in Polycythemia Vera Patients

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)I interviewed Dr. Kiladjian at ASH in 2016.
  • 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.

 

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