Heinz Gisslinger, MD, professor, program director, Myeloproliferative Neoplasms, the Medical University of Vienna, discusses the 6-year event-free survival (EFS) data from the phase 3 PROUD-PV (NCT01949805) and CONTI-PV (NCT02218047) trials.

The PROUD-PV and CONTI-PV trials compared the efficacy and safety of ropeginterferon alfa-2b-njft (Besremi) vs hydroxyurea (Hydrea) or best available treatment in patients with polycythemia vera. A final efficacy analysis for CONTI-PV was conducted once all patients had completed 6 years of treatment. The maximum treatment duration was 7.3 years.

At the time of the final analysis, EFS, which was defined as time to death, disease progression, or thromboembolic events, was significantly higher in patients in the ropeginterferon arm than in those in the control arm, Gisslinger says. This higher probability of EFS in patients treated with ropeginterferon alfa-2b contributed to this regimen fulfilling the treatment goals of patients with polycythemia vera, Gisslinger concludes.

Videos

Heinz Gisslinger, MD, discusses the 6-year event-free survival data from the phase 3 PROUD-PV and CONTI-PV trials.

Dr. Gisslinger on EFS Rates With Ropeginterferon Alfa-2b in Polycythemia Vera

Heinz Gisslinger, MD, Medical University of Vienna, discusses the phase III PROUD-PV study, which evaluated ropeginterferon alfa-2b (P1101) for the treatment of polycythemia vera (PV) during the American Society of Hematology (ASH) Annual Meeting.

The starting point of the study was to compare the new compound ropeginterferon alfa-2b with hydroxyurea (Hydrea), Gisslinger says. Interferons are very slow acting compounds, so the full strength of the compound will not be seen during the first year of treatment.

In the comparison study, ropeginterferon alfa-2b was found to be non-inferior to hydroxyurea with regard to efficacy. However, ropeginterferon alfa-2b was found to be superior in its total ability in comparison to hydroxyurea, which was a surprise, Gisslinger says.

View more from the 2016 ASH Annual Meeting

Heinz Gisslinger, MD

Articles

Dr. Gisslinger on EFS Rates With Ropeginterferon Alfa-2b in Polycythemia Vera

Dr. Gisslinger on a Study Comparing Ropeginterferon Alfa-2b to Hydroxyurea in PV