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Continuation Trial Confirms Symptom Reduction With Ropeginterferon Alfa-2b Therapy for PV

June 7, 2022

Mid-July 2022

Researchers confirmed ropeginterferon alfa-2b’s power to effectively reduce symptoms in patients with polycythemia vera (PV), according to study results presented by Heinz Gisslinger, MD, of the Medical University Vienna, at the European Hematology Association (EHA) 2022 Congress.1 The U.S. Food and Drug Administration approved the treatment for PV in November 2021, making it the first interferon therapy specifically approved for patients with PV.2 It is also approved by the European Medicines Agency.3

A key part of PV treatment is the prevention of thrombosis and bleeding by reducing blood counts, either through phlebotomy or cytoreductive therapy medications.4 The common first-line choice for cytoreductive therapy is hydroxyurea; interferon-alpha is another.5 In addition to its cytoreductive properties, interferon-alpha may have disease-modifying properties such as reducing the JAK2 allele burden, which may decrease the chance of progression to myelofibrosis.6 However, in elderly patients it produces a lower hematologic response rate compared to hydroxyurea and  necessitates comparatively more dose reductions and discontinuations because of toxicity.6

Ropeginterferon alfa-2b is a pegylated form of interferon-alpha with improved tolerability and reduced dosing frequency compared to other pegylated interferons.6 The PROUD-PV study was the first randomized, controlled, phase III study comparing hydroxyurea to ropeginterferon alfa-2b in the treatment of patients with early-stage PV. After one year, patients could opt to enter the continuation part of the trial, planned to last an additional five years. Interim data from the PROUD-PV continuation trial have previously been released.7 The EHA 2022 presentation included data from the full six-year period.

The full treatment group included 95 patients who received ropeginterferon alfa-2b and 74 patients in the control arm who received hydroxyurea (or best available therapy). Patient-reported symptoms as defined in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score were present in 9.5% of patients at baseline; by the sixth year of treatment, they were present in 15.7% of patients in the ropeginterferon alfa-2b arm compared to 20.7% of those receiving other treatments.

Only 18.6% of patients in the ropeginterferon alfa-2b group required phlebotomy to maintain their hematocrit at less than 45%, in contrast to 40% in the control group. At six years, 20.7% of patients in the ropeginterferon alfa-2b group (n=19) achieved a JAK2V617F allele burden of less than 1% compared to only one patient in the control group (1.4%; p=0.0001). Survival in the absence of disease progression or thromboembolic events was also significantly higher in the ropeginterferon group, with such events in only 5.3% of patients in the ropeginterferon alfa-2b arm versus 16.2% of those in the control arm (p=0.04).

The authors concluded, “Long-term ropeginterferon alfa-2b therapy fulfills treatment goals important to patients with PV: a good quality of life as indicated by a low symptom burden and phlebotomy requirement, the potential to influence myelofibrosis risk, and better event-free survival versus [best available treatment].”

Any conflicts of interest by the authors were made public at the time of presentation.

References

  1. Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b achieves patient-specific treatment goals in polycythemia vera: Final results from the PROUD/PV/Continuation-PV Studies. Abstract S196. Presented at the European Hematology Association (EHA) 2022 Congress, June 11, 2022; Vienna, Austria.
  2. S. Food and Drug Administration. FDA approves treatment for rare blood disease. November 12, 2021. Accessed June 1, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-blood-disease.
  3. European Medicines Agency. Besremi. Accessed June 7, 2022 https://www.ema.europa.eu/en/medicines/human/EPAR/besremi.
  4. Mesa RA. New guidelines from the NCCN for polycythemia vera. Clin Adv Hematol Oncol. 2017;15(11):848-850. 
  5. Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b: Efficacy and safety in different age groups. Hemasphere. 2020;4(6):e485.
  6. Tefferi A, Barbui T. Polycythemia vera and essential thrombocythemia: 2021 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(12):1599-1613.
  7. Gisslinger H, Klade C, Georgiev P, et al; PROUD-PV Study Group. 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. Lancet Haematol. 2020 Mar;7(3):e196-e208.

 

 

 

 

 

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