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General Updates | Ongoing trials in polycythemia vera: Low-PV & VERIFY

Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital & Paris Diderot University, Paris, France, comments on promising ongoing clinical trials in the field of polycythemia vera (PV). Low-PV (NCT03003325) is a study investigating the addition of low-dose ropeginterferon alfa-2b to the current standard strategy based on phlebotomies and aspirin. The one-year follow-up results have suggested a benefit for the addition of this drug and the results of the two-year follow-up are eagerly awaited. The Phase III VERIFY study (NCT05210790) is testing the efficacy of rusfertide in reducing hematocrit and hemoglobin levels without the need of phlebotomy. This interview took place virtually.

Transcript (edited for clarity)

In polycythemia vera, we didn’t have a lot of clinical trials in the recent years, but I think we have two studies that are of interest. The first one is the so-called Low-PV study, led by our Italian colleague, Tiziano Barbui, in Italy. That tests the addition of a low dose of ropeginterferon alfa-2b to the standard management of patients with low-risk PV, that is phlebotomy and aspirin. And indeed the results after one year of follow-up were already published last year the Lancet Hematology, showing a benefit for adding this low dose of interferon to the strategy of phlebotomy only, in terms of reducing the risk of disease progression...

In polycythemia vera, we didn’t have a lot of clinical trials in the recent years, but I think we have two studies that are of interest. The first one is the so-called Low-PV study, led by our Italian colleague, Tiziano Barbui, in Italy. That tests the addition of a low dose of ropeginterferon alfa-2b to the standard management of patients with low-risk PV, that is phlebotomy and aspirin. And indeed the results after one year of follow-up were already published last year the Lancet Hematology, showing a benefit for adding this low dose of interferon to the strategy of phlebotomy only, in terms of reducing the risk of disease progression. So now we wait for the final endpoint, which is after two years of follow-up of this study, that will probably be shown soon, maybe at EHA or at ASH this year, to see if these encouraging results are confirmed, and also if the remission in the mutant allele burden that was already seen after one year of follow-up is confirmed and strengthened.

The second new drug that may be of interest in patients with PV is rusfertide, which is a hepcidin mimetic that has been shown to clearly reduce the need for phlebotomy without inducing iron efficiency in patients with PV. So this drug is now tested in a Phase III trial that is starting, and we hope that this also will be a clear improvement for the management of patients, allowing to reduce the amount of hemoglobin without the need of phlebotomy and without inducing the adverse effects of iron deficiency.

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Disclosures

Advisory boards for Novartis, Abbvie, BMS, AOP Orphan.

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