ASH Clinical News August 2017 v3 | Page 33

CLINICAL NEWS
(ABC) in 38 percent (n=11), and unclassified in 14
percent (n=4). In this cohort, 91 percent of patients
with ABC DLBCL and 86 percent of patients with GCB
DLBCL achieved CR. At data cutoff (November 4,
2016), after a median duration of 9.5 months (range =
1.3-28 months), one patient’s disease had progressed,
the authors reported.
The study’s findings are limited by its small patient
population and non-randomized design.
Dr. Tilly reports receiving honoraria and travel/accom-
modation expenses from Roche Pharma.
REFERENCE
After patients completed six or
eight treatment cycles, the overall
response rate was 91 percent,
including a complete response rate
of 78 percent.
Tilly H, Sharman J, Bartlett N, et al. POLA-R-
CHP: polatuzumab vedotin combined with
rituximab, cyclophosphamide, doxorubicin,
prednisone for patients with previously
untreated diffuse large B-cell lymphoma.
Abstract #S106. Presented at the 22nd
Congress of the European Hematology
Association, June 23, 2017; Madrid, Spain.
Clinical study results in children and adults receiving
prophylactic treatment over a 6-month period 1,2
The efficacy, safety and PK of ADYNOVATE were evaluated in 2 multicenter, open-label clinical studies. The pediatric
study of children <12 years of age (N=66) evaluated the immunogenicity, efficacy, PK (as compared to ADVATE ®
[Antihemophilic Factor (Recombinant)]), and safety of ADYNOVATE twice-weekly prophylaxis (40-60 IU/kg) and
determined hemostatic efficacy in the treatment of bleeding episodes for 6 months. The pivotal trial of children and
adults ≥12 years (N=137) evaluated ADYNOVATE twice-weekly prophylaxis (40-50 IU/kg) vs on-demand (10-60 IU/kg)
treatment, and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months. 1-3
Proven prophylaxis with ADYNOVATE
ZERO
MEDIAN ABR FOR
JOINT & SPONTANEOUS 1
In pediatric patients <12 years: Joint: 0.0 (IQR: 1.9) median ABR 3 ;
Spontaneous: 0.0 (IQR: 1.9) median ABR. 3
In adults and children ≥12 years: Joint: Prophylaxis 0.0 (IQR: 2.0) median ABR
vs on-demand 38.1 (IQR: 20.1) median ABR. 1,3 Spontaneous: Prophylaxis 0.0
(IQR: 2.2) median ABR vs on-demand 21.6 (IQR: 22.0) median ABR. 1,3
Consistent dosing1
+ In the clinical studies, the majority of children and adults did not have a dose adjustment
+ 98% of adults and children (12 years and older) did not have a dose adjustment (118 of 120)
1,2
1
— Two subjects increased their dose to 60 IU/kg due to bleeding in target joints
+ 91% of children (less than 12 years) did not have a dose adjustment (60 of 66)
2
— Reported reasons for dose adjustment included FVIII trough levels <1%, increased risk of bleeding,
and bleeding episodes
Neutralizing Antibodies
Formation of neutralizing antibodies (inhibitors)
to factor VIII can occur following administration
of ADYNOVATE. Monitor patients regularly for the
development of factor VIII inhibitors by appropriate
clinical observations and laboratory tests. Perform
an assay that measures factor VIII inhibitor
concentration if the plasma factor VIII level fails to
increase as expected, or if bleeding is not controlled
with expected dose.
ADVERSE REACTIONS
The most common adverse reactions (≥1% of
subjects) reported in the clinical studies were
headache and nausea.
Please see the following page for
the Brief Summary of the ADYNOVATE
full Prescribing Information.
For full Prescribing Information,
visit www.ADYNOVATEPRO.com.
References: 1. ADYNOVATE Prescribing Information. 2. Mullins ES, Stasyshyn O, Alvarez-Román MT, et al. Extended
half-life pegylated, full-length recombinant factor VIII for prophylaxis in children with severe haemophilia A. Haemophilia.
2016 Nov 27. doi: 10.1111/hae.13119 [Epub ahead of print]. 3. Data on file.
©2017 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited o r its affiliates.
ADVATE and ADYNOVATE are trademarks or registered trademarks of Baxalta Incorporated, a wholly owned, indirect
subsidiary of Shire plc.
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