COMPARISON OF LONG-TERM EFFICACY AND SAFETY OF ROPEGINTERFERON ALFA-2B VS. HU IN POLYCYTHEMIA VERA PATIENTS AGED BELOW OR ABOVE 60 YEARS: TWO-YEAR ANALYSIS FROM THE PROUD/CONTINUATION PHASE III TRIALS
Author(s): ,
Heinz Gisslinger
Affiliations:
Department of Internal Medicine I, Clinical Division of Hematology and Hemostaseology,Medical University Vienna,Vienna,Austria
,
Christoph Klade
Affiliations:
AOP Orphan Pharmaceuticals AG,Vienna,Austria
,
Pencho Georgiev
Affiliations:
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Clinic of Hematology,Plovdiv,Bulgaria
,
Dorota Krochmalczyk
Affiliations:
Teaching Unit of the Hematology Department,University Hospital in Krakow,Krakow,Poland
,
Liana Gercheva-Kyuchukova
Affiliations:
Multiprofile Hospital for Active Treatment "Sveta Marina",Varna,Bulgaria
,
Miklos Egyed
Affiliations:
Department of Internal Medicine II,Kaposi Mor Teaching Hospital,Kaposvar,Hungary
,
Viktor Rossiev
Affiliations:
V.D. Seredavin Samara Regional Clinical Hospital,Samara,Russian Federation
,
Petr Dulicek
Affiliations:
Department of Clinical Hematology,University Hospital Hradec Kralove,Hradec Kralove,Czech Republic
,
Arpad Illes
Affiliations:
University of Debrecen, Medical and Health Science Center,Debrecen,Hungary
,
Halyna Pylypenko
Affiliations:
Department of Hematology,Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center,Cherkasy,Ukraine
,
Liliya Sivcheva
Affiliations:
First Department of Internal Medicine,Multiprofile Hospital for Active Treatment- Hristo Botev,Vratsa,Bulgaria
,
Jiri Mayer
Affiliations:
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology,Brno,Czech Republic
,
Vera Yablokova
Affiliations:
Department of Hematology,Yaroslavl Regional Clinical Hospital,Yaroslavl,Russian Federation
,
Barbara Grohmann-Izay
Affiliations:
AOP Orphan Pharmaceuticals AG,Vienna,Austria
,
Gabriele Maurer
Affiliations:
AOP Orphan Pharmaceuticals AG,Vienna,Austria
,
Hans Hasselbalch
Affiliations:
Department of Hematology,Roskilde Hospital, University of Copenhagen,Copenhagen,Denmark
,
Robert Kralovics
Affiliations:
CeMM, Research Center for Molecular Medicine of the Austrian Academy of Sciences,Vienna,Austria
Jean-Jacques Kiladjian
Affiliations:
Saint-Louis Hospital,Paris,France
EHA Library. Gisslinger H. Jun 15, 2018; 214443; S132
Heinz Gisslinger
Heinz Gisslinger
Contributions
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Abstract

Abstract: S132

Type: Oral Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 12:15 - 12:30

Location: Room A7

Background
Ropeginterferon alfa-2b (Ropeg) is a novel mono-pegylated IFNα, allowing convenient self-administration every 2 to 4 weeks. It is currently being developed for treatment of MPNs in particular PV. Hydroxyurea (HU) is the only licensed first-line therapy in high-risk patients with PV of all ages. Off-label IFNα as first-line therapy is primarily used in patients of younger age, partly because of the misconception that the risk-benefit ratio is not so favorable in elderly patients.

Aims
To analyse the difference in efficacy and safety of Ropeg and HU in two age cohorts (<60 years and ≥60 years).

Methods
254 PV patients (WHO2008 criteria) had been randomized to receive Ropeg or HU in the PROUD Study. After 12 months of treatment, 89.6% of Ropeg treated patients and 68.5% of HU treated patients continued treatment in the CONTINUATION Study. Efficacy assessment consisted of complete hematological response (CHR) rate according ELN criteria, and the rate of CHR including symptom improvement (disease-related signs including clinically significant splenomegaly and PV-related symptoms). Secondary endpoints included JAK2V617F allelic burden assessed as rate of molecular response (modified ELN criteria). Efficacy and safety analysis was done for patients <60 years (Ropeg: n=49; HU: n=39) and ≥60 years (Ropeg: n=46; HU: n=37).

Results

After 24 months of treatment, Ropeg induced higher CHR rates compared to HU, irrespective of age: 77.6% vs. 55.9% (<60 years); 63.0% vs. 42.4% (≥60 years). Higher response rates were also shown for Ropeg vs. HU for CHR including symptom improvement, similar for both age cohorts: 55.1% vs. 37.1% (<60 years); 43.5% vs. 36.1% (≥60 years). CHR rate maintenance (response maintained from first occurrence to 24 months assessment) was also higher for Ropeg and age-independent for both study treatments (Ropeg <60 years: 49.0%, ≥60 years: 37.0%; HU <60 years: 17.9%, ≥60 years: 18.9%). A similar observation for response maintenance was shown for CHR rate including symptom improvement (Ropeg <60 years: 32.7%, ≥60 years: 28.3%; HU <60 years: 15.4%, ≥60 years: 18.9%). After 24 months of treatment, partial molecular response rates were higher for Ropeg compared to HU, irrespective of age: 78.1% vs. 33.3% (<60 years) and 59.5% vs 25.0% (≥60 years). Regarding safety, Ropeg and HU treated patients showed comparable numbers of both, adverse events (89.8% vs. 92.3% <60 years, 93.5% vs. 91.9% ≥60 years) and serious adverse events (6.1% vs. 10.3% <60 years, 21.7% vs. 24.3% ≥60 years) irrespective of age.  The number of adverse drug reactions (ADRs) was comparable below 60 years (77.6% vs. 74.4%) but interestingly in the cohort ≥60 years, a trend towards a lower number of ADRs was evident for Ropeg (63.0%) vs. HU (89.2%). No serious ADRs were reported for Ropeg, but there were 4 serious ADRs (Acute Leukemia, Anemia, Leukopenia, Granulocytopenia) reported for HU (all patients aged ≥60 years).

Conclusion

A high CHR, symptom improvement and molecular response (JAK2V617F) achieved by long-term treatment with Ropeg was shown, with an advantage over HU independent of age.  The safety analysis in patients ≥60 years also showed a positive trend regarding less ADRs and less serious ADRs for Ropeg vs. HU. These data indicate that Ropeg provides a valuable, efficacious and safe new treatment option for PV patients of all ages including elderly.

Session topic: 16. Myeloproliferative neoplasms - Clinical

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