Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial
Study (n=127) reports use of ropeginterferon alfa-2b on top of standard phlebotomy regimen was linked to higher response rate (maintenance of median haematocrit values of ≤45% without progressive disease during 12-month period in 84 vs. 60%, p=0.0075).vs. phlebotomy alone.
Source:
The Lancet Haematology
SPS commentary:
The data safety monitoring board decided to stop patient accrual for overwhelming efficacy and to continue the follow-up, as per protocol. Authors of a related commentary highlight that the use of interferon for the treatment of myeloproliferative neoplasms has a long tradition. However, toxicity led to discontinuation of treatment in almost a quarter of patients. Ropeginterferon alfa-2b however is a novel, long-acting, next-generation monopegylated interferon consisting of only one isoform, allowing application every other week. Authors’ comment that the favourable toxicity profile and low discontinuation rate shown in this study might have implications for changing the current management of low-risk patients with polycythaemia vera.