Ropeginterferon Alfa Reduces JAK2 Allele Burden Over Long Term in PV

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Ropeginterferon Alfa Reduces JAK2 Allele Burden Over Long Term in PV

Douglas A. Tremblay, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, New York, discusses the long-term data supporting ropeginterferon alfa-2b-njft (Besremi) as treatment in patients with polycythemia vera (PV).

The phase 3, open-label, randomized clinical trial PROUD-PV and its phase 3b extension trial CONTINUATION-PV (NCT01949805, NCT02218047) enrolled patients with PV to receive ropeginterferon or hydroxyurea. After 1 year, those who entered CONTINUATION-PV could continue receiving ropeginterferon for 5 years. Long-term follow-up showed the complete hematologic response (CHR) rate was 55.8% in the ropeginterferon arm vs 44% in the control arm.

Tremblay says that an advantage of ropeginterferon is its ability to reduce the JAK2 allele burden, which declined from a median of 37.3% at baseline to 8.5% at 60 months in this trial. JAK2 allele burden can serve as a surrogate end point for other outcomes such as thrombosis and disease progression to secondary myelofibrosis or leukemic transformation.

According to Tremblay, there were also encouraging safety data showing that it was well tolerated over the 5-year period and patients were able to continue taking the drug. The rates of adverse events and serious adverse events were comparable between ropeginterferon and the control arm.

TRANSCRIPTION:

0:10 | The efficacy looks really promising in the long-term follow-up of this longstanding trial of ropeginterferon. To orient everyone, ropeginterferon is an injectable interferon, which is given every 2 weeks. It has distinct advantages, which is shown into the long-term follow-up as it relates to reducing the amount of JAK2 allele burden, which we think is very promising in terms of a surrogate end point for outcomes such as thrombosis and disease progression. There's also encouraging safety data that with long-term therapy, patients generally are able to stay on the drug and do well. So I think this was encouraging results all around.