Summary: GSK and Genmab announce top-line results from a study of Arzerra
(ofatumumab) in rituximab refractory follicular NHL.
London, UK and Copenhagen, Denmark; August 17, 2009 - GlaxoSmithKline (GSK) and
Genmab A/S (OMX: GEN) announced today top-line results from an international
multi-center study of Arzerra(TM) (ofatumumab) in rituximab refractory
follicular non-Hodgkin's lymphoma (NHL).
A total of 116 patients were treated in the study, including 30 patients treated
with 500 mg ofatumumab and 86 patients treated with 1000 mg of ofatumumab. The
patients in the study were highly refractory. Forty-nine percent of patients
were refractory to their last chemotherapy treatment. Patients in the study had
previously received a median of 4 prior treatment regimens. The primary endpoint
was objective response (International Working Group Criteria) over six months
from the start of treatment in the 1000 mg dose population.
The overall response rate (ORR) in the 1000 mg treatment arm was 10%, including
one complete response and 8 partial responses. In addition, 50% (43) of patients
in the 1000 mg treatment arm had stable disease. The overall response rate in
the total population was 11%.
The ORR among patients who were refractory to prior rituximab monotherapy (n=27)
was 22%. For patients considered refractory to rituximab in combination with
chemotherapy the response rate was 7% and among patients considered refractory
to rituximab maintenance the response rate was 9%. The median duration of
response in the 1000 mg treatment arm was 6 months and the progression free
survival was 6 months.
There were no unexpected safety findings reported during treatment and within 30
days after last infusion. The most common adverse events (greater than 10%) were
rash, urticaria, pruritus, fatigue, nausea, pyrexia and cough.
“The results of this study demonstrate the activity of ofatumumab in patients
who had not responded to prior treatment with a CD20 antibody. The response rate
in patients refractory to rituximab monotherapy is of interest and warrants
further study. We are committed to the further development of ofatumumab in
NHL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
“Clearly, this is a challenging patient population to treat with a single agent
CD20 antibody. We are committed to evaluating ofatumumab in combination with
other agents in this patient population to develop new treatment options for
these difficult to treat patients,” said Kathy Rouan, Ph.D., Vice President and
Medicines Development Leader at GSK.
GSK and Genmab continue to review the study results and discuss the development
strategy for ofatumumab in NHL.
About the study
Patients in this study failed to achieve at least a partial response to
rituximab in combination with chemotherapy, had disease progression while on
rituximab or had disease progression following a response within 6 months of the
last dose of rituximab. Patients received one infusion of 300 mg of ofatumumab
followed by 7 weekly infusions of 500 mg or 1000 mg of ofatumumab. Disease
status was assessed every 3 months until month 12, then every 6 months until
month 24. Patients will be followed every 6 months thereafter until month 60.
The protocol was amended in 2007 to discontinue enrollment in the 500 mg dosing
allowing full recruitment at 1000 mg.
The objective of the study was to determine the efficacy and safety of
ofatumumab in rituximab refractory follicular NHL. The primary endpoint of the
study was objective response as measured over a 6 month period from start of
treatment and assessed by an Independent endpoints Review Committee according to
the standardized criteria for NHL. Secondary endpoints include duration of
response and safety.
About ofatumumab
Ofatumumab is an investigational, fully human monoclonal antibody that binds
specifically to the small and large extracellular loops of the CD20 molecule
proximal to the cell membrane. The CD20 molecule is a key target in B-cell
malignancy therapy because it is expressed on most B-cells.
Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. It is not yet approved in any
country.
Conference Call
Genmab will hold a conference call to discuss the ofatumumab results August 18,
2009, at
7:30 am CEST
6:30 am BST
1:30 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1 888-551-9020 (in the US) and provide conference ID number 4110106
+1 719-457-2654 (outside the US) and provide conference ID number 4110106
To listen to a live webcast of the call please visit www.genmab.com.
About GlaxoSmithKline (GSK)
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better, and live longer. For company
information, visit GlaxoSmithKline at www.gsk.com.
GSK Oncology is dedicated to producing innovations in cancer that will make
profound differences in the lives of patients. Through GSK's revolutionary
‘bench to bedside' approach, we are transforming the way treatments are
discovered and developed, resulting in one of the most robust pipelines in the
oncology sector.
GSK's BioPharm R&D division has a rich early pipeline based on cutting edge
molecular biology and genetics technology and a mature late-stage portfolio that
will provide important medicines to oncology.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
GSK Enquiries
UK Media enquiries:
Philip Thomson +44 20 8047 5502
David Outhwaite +44 20 8047 5502
Stephen Rea +44 20 8047 5502
US Media enquiries:
Mary A. Rhyne +1 919 699 1758
European Analyst/Investor enquiries:
David Mawdsley +44 20 8047 5564
Sally Ferguson +44 20 8047 5543
Gary Davies +44 20 8047 5503
US Analyst/Investor enquiries:
Tom Curry +1 215 751 5419
Jen Hill Baxter +1 215 751 7002
Genmab Enquiries
Helle Husted, Vice President, Investor Relations
T: +45 33 44 77 30
M: +45 25 27 47 13
E: h.husted@genmab.com
Cautionary statement regarding forward-looking statements for GSK:
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s Annual
Report on Form 20-F for 2007.
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Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
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Stock Exchange Release no. 31/2009
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GlaxoSmithKline and Genmab Announce Results from a Study of Arzerra in Rituximab Refractory Follicular NHL
| Source: Genmab A/S
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