Company Announcement
- Trial did not meet the primary endpoint of Progression
Free Survival
- Data to be further analyzed in the coming
months
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 patients.
"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 treatment.
About CLL
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. 3,5 The majority of patients with CLL
have at least one comorbidity such as hypertension, diabetes,
cardiovascular disease, or COPD. 6
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 alemtuzumab.
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.
GSK
enquiries:
UK Media
enquiries: David
Mawdsley +44
(0) 20 8047
5502
(London)
Simon
Steel +44
(0) 20 8047
5502
(London)
David
Daley +44
(0) 20 8047
5502
(London)
Catherine
Hartley +44
(0) 20 8047
5502
(London)
Sarah
Spencer +44
(0) 20 8047
5502
(London)
US Media
enquiries: Melinda
Stubbee +1
919 483
2510
(North Carolina)
Bernadette
King +1
215 778
3027
(Philadelphia)
Anna
Padula
+1 215 751
4271 (Philadelphia)
Karen
Collins
+1 919 483
2527 (North
Carolina)
Stephen
Rea +1
215 751
4394 (Philadelphia)
Analyst/Investor
enquiries: Ziba
Shamsi +44
(0) 20 8047
5543 (London)
Kirsty Collins (SRI &
CG) +44 (0) 20 8047
5534 (London)
Tom
Curry +
1 215 751
5419 (Philadelphia)
Gary
Davies +44
(0) 20 8047
5503 (London)
James
Dodwell
+44 (0) 20 8047
2406 (London)
Jeff
McLaughlin
+1 215 751
7002 (Philadelphia)
Lucy
Singah
+44 (0) 20 8047
2248 (London)
Genmab enquiries:
Rachel Curtis
Gravesen
T: +45 33 44 77 20
M: +45 25 12 62 60
E:
r.gravesen@genmab.com
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).
| Registered in England &
Wales: |
| No. 3888792 |
| |
| Registered Office: |
| 980 Great West Road |
| Brentford, Middlesex |
| TW8 9GS |
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.
http://www.lls.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/.
Accessed January 3, 2014.
3 American Cancer Society. What are the key statistics for
chronic lymphocytic leukemia?
http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-key-statistics.
Accessed January 3, 2014.
4 Leukemia & Lymphoma Society. The CLL Guide.
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/leukemia/pdf/cllguide.pdf.
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.
http://annonc.oxfordjournals.org/content/22/suppl_6/vi50.full.
Accessed 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. 2007;139, 255-264.
| Company Announcement no. 32 |
| CVR no. 2102 3884 |
| |
| Genmab A/S |
| Bredgade 34E |
| 1260 Copenhagen K |
| Denmark |
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