ASH Clinical News ACN_4.3_FULL-ISSUE-DIGITAL | Page 29

CLINICAL NEWS
interruptions in 16 people ( 26 %).
Except for IRRs , the safety profile of the brentuximab vedotin and nivolumab were similar to those observed with each agent administered individually .
“ Our results are promising in the context of other salvage therapy studies in relapsed / refractory HL , a setting in which no randomized studies have been performed to define a single standard of care regimen prior to AHCT ,” the authors concluded .
However , they noted that the study is limited by its short-term follow-up and lack of a comparator arm . “ Long-term follow-up of the durability of disease control will be critical in assessing the full therapeutic impact of [ this combination ],” the researchers added . Also , the study population only included patients who were naïve to prior brentuximab vedotin and nivolumab , and outcomes may not be generalizable to other patients with
relapsed / refractory HL .
An ongoing trial is evaluating brentuximab vedotin plus nivolumab in patients with relapsed / refractory HL who are ineligible for AHCT or after AHCT failure .
Seattle Genetics and Bristol-Myers Squibb supported the study .
The corresponding authors report financial support from Seattle Genetics , Bristol-Myers Squibb , MedImmune , Merck , Immune Design , Genentech , Pharmacyclics ,
Janssen , Affimed , ImaginAb , KITE , Forty Seven , Celgene , AstraZeneca , Millennium , Pfizer , and Novartis . Some of the authors are employees of and have equity ownership in Seattle Genetics , which provided editorial support for the original manuscript .
REFERENCE
Herrera AF , Moskowitz AJ , Bartlett NL , et al . Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma . Blood . 2017 November 30 . [ Epub ahead of print ]
5 ” . 75 ”
FVIII
plasma concentration
1000
FVIII levels through 48 hours ( N = 18 )
KOVALTRY ® Advate ®
FVIII IU / dL
100
10
KOVALTRY ®
10.0 IU / dL
1
0 6 12 18 24 30 36 42 48
Time , h
Data are geometric means , based on chromogenic assay .
Print-only content
Advate ®
4.5 IU / dL
S : 9.75 ”
T : 10 ”
Compared to Advate ® , KOVALTRY ® demonstrated 2 :
% % % %
higher AUC 0-inf longer half-life lower clearance higher FVIII levels
SELECTED IMPORTANT SAFETY INFORMATION
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII .
Catheter-related infections may occur when KOVALTRY ® is administered via central venous access devices ( CVADs ). These infections have not been associated with the product itself .
The most frequently reported adverse reactions in clinical trials ( ≥3 %) were headache , pyrexia , and pruritus .
For additional risk and use information , please see Brief Summary on following pages .
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA . Visit www . fda . gov / medwatch or call 1-800-FDA-1088 .
References : 1 . KOVALTRY ® [ prescribing information ]. Whippany , NJ : Bayer HealthCare LLC ; 2016 . 2 . Shah A , Solms A , Garmann D , et al . Improved pharmacokinetics with BAY 81-8973 versus antihemophilic factor ( recombinant ) plasma / albumin-free method : a randomized pharmacokinetic study in patients with severe hemophilia A [ Published online December 22 , 2016 ]. Clin Pharmacokinet . doi : 10.1007 / s40262-016-0492-2 . 3 . Data on file . Bayer HealthCare Pharmaceuticals , Inc ; 2016 .
Bayer , the Bayer Cross , and KOVALTRY are registered trademarks of Bayer . Advate is a registered trademark of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . © 2017 Bayer . All rights reserved . Printed in USA 12 / 17 PP-675-US-1242
. 5 ” Gutter FS : 6.75 ”