On Location Conference Coverage
252 [50%]) and febrile neutropenia (11 [2%] and
34 [7%]).
In addition, patients in the R 2 arm had
higher rates of grade 3/4 rash, likely attributable
to lenalidomide (7% and 1%).
Reports of secondary primary malignan-
cies were similar: 7 percent in the R 2 arm and 9
percent in the R-chemo arm.
“These results show that R 2 , an immuno-
modulatory approach, is a potential first-
line option for patients with FL,” Dr. Fowler
concluded, adding that survival data were
immature and requires longer follow-up. The
reliance on physician’s choice of chemotherapy
in the R-chemo arm also may have confounded
the findings.
The corresponding authors report financial
support from AbbVie, Genentech, Celgene,
Merck, Roche, Janssen, Bristol-Myers Squibb,
and Gilead Sciences.
Fowler NH, Morschhauser F, Feugier P, et al. RELEVANCE: Phase III randomized
study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab,
followed by rituximab maintenance, in patients with previously untreated
follicular lymphoma. Abstract #7500. Presented at the 2018 American Society of
Clinical Oncology Annual Meeting, June 3, 2018; Chicago, IL.
REFERENCE
T:15
S:14.7
EXPLORE THE COVERAGE
OF KOVALTRY ®
Cross-over PK study: KOVALTRY ® and Advate ®2,3
Study summary
The PK profi les of KOVALTRY ® and Advate ® were compared in a single-dose, open-label,
randomized, cross-over study of 18 PTPs
(aged 18–65 years) with severe hemophilia A
KOVALTRY ®
KOVALTRY ®
(n=9)
(n=9)
Patients were randomized to a single infusion of
either drug (50 IU/kg, n=9 for each arm), then after
Advate ®
Advate ®
≥3-day
(n=9)
(n=9)
a ≥3-day washout period they were crossed over to
washout period
a single infusion of the other treatment
Plasma samples were collected predose and postdose (at 0.25, 0.5, 1, 3, 6, 8, 24, 30, and
48 hours)
PK results
Cross-over PK study results (geometric mean [%CV]) following single-dose
administration (50 IU/kg) of KOVALTRY ® and Advate ® in 18 patients
Chromogenic assay KOVALTRY ® Advate ® P value
AUC 0-inf
(IU•h/dL)
C max
(IU/dL)
t 1/2
(h)
CL
(dL/h/kg) 2440
(28.5) 1650
(31.0) <0.0001
151
(19.9) 153
(17.1) 0.32
13.9
(25.1) 12.0
(23.3) <0.0001
0.021
(28.5) 0.030
(31.0) <0.0001
AUC 0-inf =area under the curve from time 0 to infinity.
CL=clearance.
CV=coefficient of variation.
PTP=previously treated patient.
SELECTED IMPORTANT SAFETY INFORMATION
KOVALTRY ® may contain trace amounts of mouse and hamster proteins. Patients treated
with this product may develop hypersensitivity to these non-human mammalian proteins.
Neutralizing antibody (inhibitor) formation can occur following administration of KOVALTRY ® .
Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all
Factor VIII products. Carefully monitor patients for the development of Factor VIII inhibitors,
using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII
activity levels are not attained or if bleeding is not controlled as expected with administered dose,
suspect the presence of an inhibitor.
.5”Gutter