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As discussed in our last editorial theme, the pegylated forms of interferon-alpha improve treatment compliance and lower the needed dosing. This leads to a better safety profile, especially for older patients with myeloproliferative neoplasms (MPN).
In January 2020, Heinz Gisslinger and colleagues reported the results of the phase III trial, PROUD-PV, and its extension study, the CONTINUATION-PV trial.1 Please refer to this previous article on the MPN Hub for a summary of the study design, patient baseline characteristics, and key clinical outcomes. Here, we summarize the recently published subanalysis of the PROUD-PV trial on the use of ropeginterferon alfa-2b (ropeg) versus hydroxyurea (HU) in patients with polycythemia vera (PV) according to their age.2
Age subanalysis included all patients enrolled in the CONTINUATION-PV study:
Overall, the study population was considered young, with a median age of 58 years and 59 years in the ropeg and HU arms, respectively. When grouped into < 60 years and ≥ 60 years, age groups were balanced for the most relevant patient characteristics.
After 24 months from ropeg treatment initiation, patients ≥ 60 years received a median dose of 500 μg every 2–4 weeks, while patients < 60 received a median of 350 μg. In the control arm, both groups received HU at a median dose of 1000 mg/day.
Figure 1. Efficacy and safety of ropeg vs HU in patients with PV2
AE, adverse event; CHR, complete hematological response; HU, hydroxyurea; ropeg, ropeginterferon alfa-2b.
†Including one death.
The PROUD-PV and CONTINUATION-PV phase III trials led to the approval of ropeg in Europe as monotherapy for PV without symptomatic splenomegaly, and it is currently under evaluation by the U.S. Food and Drug Administration (FDA). A final decision is expected to take place soon.
This subanalysis on the efficacy and safety according to age confirms that ropeg is safe and efficacious in patients older than 60 years. Due to its favorable safety profile and good compliance, the authors advocate that ropeg should substitute HU in the current treatment recommendations for high-risk PV.
PROUD-PV/CONTINUATION-PV studies: benefits of ropeg IFN alfa-2b for the treatment of PV
The MPN Hub were pleased to speak to Jean-Jacques Kiladjian, University of Paris, Paris, FR, during the 61st American Society of Hematology (ASH) meeting in...
5-year results from the PROUD-PV and CONTINUATION-PV studies
Ropeginterferon alfa-2b is a novel pegylated recombinant interferon, approved in the EU as monotherapy for the treatment of adults with polycythemia vera (PV) without symptomatic...
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