Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study

In PROUD-PV, treatment with ropeginterferon alfa-2b did not show non-inferiority compared to treatment with hydroxycarbamide: 21% vs 28% respectively met the composite primary endpoint of complete haematological response with normal spleen size.

SPS commentary:

However, in CONTINUATION-PV, complete haematological response with improved disease burden was met in 50 (53%) of 95 patients in the ropeginterferonalfa-2b group vs 28 (38%) of 74 patients in the hydroxyurea group, p=0.044 at 36 months (not statistically significant).

The Lancet Haematology