GSK and Genmab announce top-line results from a Phase III study of ofatumumab
versus physicians' choice for bulky fludarabine-refractory CLL
*Trial did not meet the primary endpoint of Progression Free Survival
*Data to be further analyzed in the coming months
COPENHAGEN, Denmark, June 27, 2014 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc
(LSE:GSK) and Genmab A/S (Copenhagen:GEN) announced today that the Phase III
study of ofatumumab (Arzerra(tm)) versus physicians' choice in patients with
bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL) did not meet
its primary endpoint of progression free survival (PFS). The median PFS, as
assessed by the Independent Review Committee, was 5.36 months for ofatumumab
and 3.61 months for physicians' choice (Hazard Ratio 0.79, p=0.267).
The result reported today is headline data; the full analysis of safety and
efficacy data is underway and will be completed in the coming months. This
study (OMB114242) was conducted to meet the requirements from the EU
Commission for the conditional approval of ofatumumab for the treatment of CLL
in patients who are refractory to fludarabine and alemtuzumab. The current
indications in the EU or US do not include bulky fludarabine-refractory CLL
"It was our priority to share this result with the scientific community as
soon it became available. We will now work to further analyse the data and to
better understand the totality of the efficacy and safety findings," said Dr.
Rafael Amado, Head of Oncology R&D at GSK. "We are very grateful to the CLL
patients who participated in this trial."
"Although ofatumumab performed broadly in-line with previous data, today's
result is disappointing. Based on this result, we do not anticipate applying
for a label expansion for ofatumumab in this specific refractory CLL
population," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This Phase III open-label study randomised 122 patients with bulky
fludarabine-refractory CLL to one of two treatment arms. Patients were
randomised to either ofatumumab or physicians' choice (2:1). Patients
randomised to ofatumumab received an initial dose of 300 mg, followed 1 week
later by 2,000 mg once weekly for 7 weeks, followed 4 weeks later by one
infusion of 2,000 mg every 4 weeks for a total treatment duration of 6 to 12
months. Patients in the physicians' choice arm received a treatment regimen
chosen by a physician for up to six months.
The primary endpoint of the study was progression free survival as adjudicated
by the Independent Review Committee. Secondary objectives are to evaluate
response, overall survival, safety, tolerability and health-related quality of
life of subjects treated with ofatumumab versus physicians' choice of
CLL, the most commonly diagnosed adult leukaemia in Western countries,
accounts for approximately one-third of all cases of leukaemia. ^1,2,3 In the
U.S., it is estimated that more than 105,000 people currently live with or
have been previously treated for CLL and an estimated 15,680 new cases of CLL
were diagnosed in the past year. ^3,4 The average age of diagnosis is 72 years
old, and approximately 90 per cent of patients with CLL are estimated to be
over the age of 55. ^ 3,5The majority of patients with CLL have at least one
comorbidity such as hypertension, diabetes, cardiovascular disease, or COPD. ^
Important Safety Information
The following Important Safety Information is based on the Highlights section
of the Prescribing Information for Arzerra. Please consult the full
prescribing information for all the labeled safety information for Arzerra.
The most common adverse reactions (>=10%) seen in previously untreated CLL
patients were infusion reactions, neutropenia, rash, anaemia, and respiratory
tract infections. Much less common but potentially very serious adverse
reactions include severe infusion reactions, hepatitis B virus reactivation,
hepatitis B virus infection, progressive multifocal leukoencephalopathy, and
tumor lysis syndrome.
For full U.S. Prescribing Information, including Boxed Warning, visit
https://www.gsksource.com/gskprm/htdocs/documents/ARZERRA.PDF. For the
approved indications and European Union (EU) Summary of Product
Characteristics (SPC) visit http://health.gsk.com/.
About ofatumumab (Arzerra)
Ofatumumab is a monoclonal antibody that is designed to target the CD20
molecule found on the surface of CLL cells and normal B lymphocytes.
In the U.S., ofatumumab is approved for use in combination with chlorambucil
for the treatment of previously untreated patients with CLL for whom
fludarabine-based therapy is considered inappropriate. Ofatumumab is also
approved for first-line use in Russia.
In more than 50 countries worldwide, ofatumumab is indicated as monotherapy
for the treatment of patients with CLL refractory to fludarabine and
Ofatumumab is being developed under a co-development and collaboration
agreement between Genmab and GSK.
Arzerra is a trademark of the GSK group of companies.
GSK - 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 further information
please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company currently has one
marketed antibody, Arzerra^(r) (ofatumumab) for the treatment of certain
chronic lymphocytic leukemia indications, a clinical pipeline with both late
and early stage programs, and an innovative pre-clinical pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody(r) platform for generation of bispecific
antibodies, and the HexaBody(tm) platform which creates effector function
enhanced antibodies. Genmab's deep antibody expertise is expected to provide a
stream of future product candidates. Partnering of selected innovative
product candidates and technologies is a key focus of Genmab's strategy and
the company has alliances with top tier pharmaceutical and biotechnology
companies. For more information visit www.genmab.com.
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Cautionary statement regarding forward-looking statements
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. Such factors include, but are not limited to, those described under
Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
Forward Looking Statement for Genmab
This Company Announcement contains forward looking statements. The words
"believe", "expect", "anticipate", "intend" and "plan" and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to
the outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment
in relation to our business area and markets, our inability to attract and
retain suitably qualified personnel, the unenforceability or lack of
protection of our patents and proprietary rights, our relationships with
affiliated entities, changes and developments in technology which may render
our products obsolete, and other factors. For a further discussion of these
risks, please refer to the risk management sections in Genmab's most recent
financial reports, which are available on www.genmab.com. Genmab does not
undertake any obligation to update or revise forward looking statements in
this Company Announcement nor to confirm such statements in relation to actual
results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
Y-shaped Genmab logo^(r); Genmab in combination with the Y-shaped Genmab
logo(tm); the DuoBody logo(tm); the HexaBody logo(tm); HuMax^(r);
HuMax-CD20^(r); DuoBody^(r); HexaBody(tm) and UniBody^(r).
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^1 Wadhwa P, Morrison VA. Infectious complications of chronic lymphocytic
leukemia. Seminars in Oncology. 2006;33:240-249.
http://www.cllsupport.org.uk/infections.pdf. Accessed February 12, 2014.
^2 Leukemia & Lymphoma Society. Chronic Lymphocytic Leukemia.
Accessed January 3, 2014.
^3 American Cancer Society. What are the key statistics for chronic
Accessed January 3, 2014.
^4 Leukemia & Lymphoma Society. The CLL Guide.
Accessed January 3, 2014.
^5 Eichhorst B, Hallek M, Dreyling M. Chronic lymphocytic leukemia: ESMO
clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol.
2011;22 Suppl 2, 50-54.
January 3, 2014.
^6 Shanafelt, TD, et al. Quality of life in chronic lymphocytic leukemia: an
international survey of 1482 patients. British Journal of Hematology.
Company Announcement no. 32
CVR no. 2102 3884
1260 Copenhagen K
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