On Location
Conference Coverage
BREAKTHROUGHS IN BLOOD DISORDERS
his month, we continue our coverage of
the European Hematology Association’s
22nd Congress, which was held June 22-25 in
Madrid, Spain. More than 10,000 international
hematologists met to share the latest results from
clinical and translational research in hematologic
disorders and emerging techniques for diagnosis and risk
assessment.
Here, we present highlights from the meeting,
including new combination therapies for myeloma,
polatuzumab vedotin in diffuse large B-cell lymphoma,
and a look at the risks and benefits of anticoagulation in
cancer patients with venous thromboembolism.
Plaza de Cibeles, Madrid, Spain
Ropeginterferon Alfa-2B
Versus Hydroxyurea in Patients
With Polycythemia Vera
Treatment with ropeginterferon alfa-2B, a mono-pegylated proline interferon, reduced
JAK2 allele burden in patients with polycythemia vera (PV) and appeared to modify
the underlying disease, according to an analysis of the randomized, controlled,
phase III PROUD-PV study. Unlike hydroxyurea (HU), a standard treatment for PV,
ropeginterferon specifically targets JAK2 mutant progenitor cells, which contributes to
a “strikingly different” JAK2 allele burden in patients’ peripheral blood (PB) and bone
marrow (BM), as reported by the investigators, led by Jean-Jacques Kiladjian, MD,
PhD, from Hôpital Saint-Louis in Paris, France.
Dr. Kiladjian presented results at the 22nd Congress of the European Hematology
Association.
The PROUD-PV trial included 257 patients from 13 European countries who re-
ceived either ropeginterferon alfa-2B or HU to assess the correlation between evolution
of JAK2 V617F in PB and the effect of therapy on malignant clones in the BM.
For this analysis, the researchers looked specifically at the 13 patients enrolled from
France (mean age = 55 years; range not provided) because that cohort had available data
about bone marrow progenitor cells, specifically the presence or absence of erythropoietin.
“The presence of colonies without erythropoietin is a hallmark of PV,” the authors noted.
In that group, five patients received ropeginterferon and eight received HU.
In the overall PROUD-PV population, ropeginterferon was non-inferior to HU for
complete hematologic response (primary endpoint; per European LeukemiaNet criteria)
at 12 months: 43.1 percent versus 45.6 percent (p value not provided). In the French
group, rates were similar: 40 percent in those receiving ropeginterferon and 50 percent
in those receiving HU (p value not provided).
Over the course of follow-up, all patients experienced a reduction in their JAK2 allele
burden:
• baseline: 39.4% (ropeginterferon group) and 46.5% (HU group)
• 6 months: 29.1% and 25.8%
• 12 months: 13.8% and 33.2%
No patients in either cohort achieved complete molecular response (MR; secondary
endpoint), but partial MR was achieved in 40 percent of patients treated with
ropeginterferon and 25 percent of patients treated with HU (p value not provided).
Ten patients had data on BM progenitor cells available (3 in the ropeginterferon
group and 7 in the HU group). The authors observed that patients in the ropeginterferon
group had a greater reduction in the proportion of colonies without erythropoietin
(endogenous erythroid colonies) from baseline to 12 months, compared with those in
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ASH Clinical News
the HU group (median decreases = 64% and 25%; ranges and p value not provided),
indicating greater disease control.
In addition, clonal architecture analysis showed that all patients treated with
ropeginterferon experienced a “profound decrease” in the percentage of JAK2 V617F
mutant colonies: The mean ratio of mutant versus wild-type JAK2 colonies decreased
from 96 percent at baseline to 46 percent at 12 months. In the HU-treated group, just
one patient experienced a decrease (from 87% to 79%).
“Such targeted impact of [ropeginterferon] suggests that sustained long-term MR
may only be achieved with interferon-alfa-based treatment,” the authors concluded.
The study is limited by its small patient population.
Dr. Kiladjian reports research funding from AOP Orphan Pharmaceuticals AG.
REFERENCE
Kiladjian JJ, Cassinat B, Soret-Dulphy J, et al. Molecular response to hydroxyurea and ropeginterferon alfa-2B in the PROUD-PV randomized phase 3
trial. Abstract #S787. Presented at the 22nd Congress of the European Hematology Association, June 25, 2017; Madrid, Spain.
Fourth Drug’s the Charm?
Comparing Combination
Therapies in the Myeloma XI Trial
Triplet combinations of anti-myeloma induction therapies lead to
deeper, longer remissions than doublet combinations. Results from the
U.K. National Cancer Research Institute’s Myeloma XI trial presented
at the 22nd Co