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 Learning Center. Gisslinger H. Jun 15, 2018; 214443
Heinz Gisslinger
Heinz Gisslinger

Access to EHA Members only content is an EHA membership benefit. Click here to join EHA or renew your membership here.


Abstract
Discussion Forum (0)
Rate & Comment (0)

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

Code of conduct/disclaimer available in General Terms & Conditions
Anonymous User Privacy Preferences

Strictly Necessary Cookies (Always Active)

MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.


Performance Cookies

Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.



Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.


Save Settings