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So, 10.12.2017 14:00
pts20171210001 Health/Medicine, Science/Technology
AOP Orphan announces two-year results on Ropeginterferon alfa-2bin PV
At the American Society of Hematology (ASH) Annual Meeting 2017
Vienna, Austria/Atlanta, USA (pts001/10.12.2017/14:00) -
* High rates and durable Clinical and Hematological response were achieved with Ropeginterferon alfa-2b at 24 months of treatment
Vienna, 10 December 2017: AOP Orphan Pharmaceuticals AG (AOP Orphan) announces that the latest follow-up results on Ropeginterferon alfa-2b from AOP Orphan´s trial CONTINUATION-PV for patients with Polycythemia Vera (PV) were presented at ASH 2017.
CONTINUATION-PV is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with polycythemia vera who previously participated in the pivotal PROUD-PV study.
Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide. AOP Orphan´s submission for marketing authorization in the EU is currently under EMA review.
At 12 months (PROUD-PV study), Ropeginterferon alfa-2b was shown to be non-inferior in Complete Hematologic Response (CHR) and to have a significantly better safety and tolerability profile compared to hydroxyurea (HU).
At 24 months, treatment with Ropeginterferon alfa-2b achieved a high CHR of 70.5%, significantly higher than a CHR of 49.3% with HU/BAT (p=0.0101).
Importantly, response rates increased steadily in the Ropeginterferon alfa-2b-treated patients over the two-year treatment period in contrast to HU/BAT. Also, the composite endpoint, CHR including disease symptom improvement, was higher in patients treated with Ropeginterferon alfa-2b versus HU/BAT at 24 months (49.5% versus 36.6%, p=0.1183).
A pronounced treatment effect of Ropeginterferon alfa-2b was also observed on the mutant JAK2 allele burden at 24 months: 69.6% of patients treated with Ropeginterferon alfa-2b compared to only 28.6% on HU/BAT achieved partial molecular response (p=0.0046).
A comparable number of patients experienced treatment-related adverse events (70.1% for Ropeginterferon alfa-2b and 77.2% for HU). Events of special interest for the interferon alfa-class, in particular thyroid disorders and depression were below 5% in the Ropeginterferon alfa-2b arm.
Professor Heinz Gisslinger from the Medical University of Vienna, presenting the results at ASH stated, "the observed superior efficacy of Ropeginterferon alfa-2b over hydroxyurea/best-available-therapy after 24 months, is a clear proof of the long-term value of this treatment modality. Thus, Ropeginterferon alfa-2b will provide a valuable and safe new first line therapy for PV patients".
Professor Jean-Jacques Kiladjian from the Saint-Louis Hospital & Paris Diderot University in France, concluded, "the disease modification capability of Ropeginterferon alfa-2b suggested by a significant reduction of mutant JAK2 allelic burden and the malignant clone, holds promise for improvement of progression-free survival and long-term patient benefit."
About Ropeginterferon alfa-2b
About Polycythemia Vera
About AOP Orphan Pharmaceuticals AG