Company Announcement
- No statistically significant difference in progression
free survival in ofatumumab plus chemotherapy treatment arm
compared to rituximab plus chemotherapy
- Detailed data will be presented at an upcoming medical
conference
GlaxoSmithKline plc (LSE:GSK) and Genmab
A/S (Copenhagen:GEN) announced today that the
Phase III study (ORCHARRD) of ofatumumab (Arzerra(tm)) plus
chemotherapy versus rituximab plus chemotherapy to treat relapsed
or refractory diffuse large B-cell lymphoma (DLBCL) did not meet
its primary endpoint as there was no statistically significant
difference in progression free survival (PFS) between the treatment
arms.
There were no differences in adverse events (AEs) leading to
treatment discontinuation, Grade >=3 AEs, severe adverse
events (SAEs) or fatal SAEs between the treatment arms.
However, there were more dose interruptions and delays due to
infusion reactions and increased serum creatinine in the ofatumumab
plus chemotherapy arm, which require further analysis.
"We are disappointed that the ORCHARRD study did not meet its
primary endpoint. We will further analyze these results to better
understand the findings and how they add to our collective
knowledge of this disease," said Dr. Rafael Amado, Head of Oncology
R&D, GlaxoSmithKline.
"We plan to submit detailed data from the ofatumumab ORCHARRD
study in DLBCL for presentation at a medical conference later this
year, which we hope will provide further clarity on today's
headline results. Based on today's results we are unlikely to move
forward with a regulatory filing," said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab.
About the ORCHARRD study
This pivotal Phase III randomized study included 447 patients
who were refractory to, or had relapsed following, first-line
treatment with rituximab in combination with a chemotherapy regimen
containing anthracycline or anthracenedione, and were
eligible for autologous stem cell transplant (ASCT). Patients in
the study were randomized 1:1 to receive three cycles of either
ofatumumab or rituximab in combination with DHAP (dexamethasone,
cytarabine and cisplatin) salvage chemotherapy. After the third
treatment cycle, patients who obtained a complete or partial
response received high dose chemotherapy followed by ASCT. The
primary endpoint of the study was progression free survival.
The ORCHARRD study was conducted in collaboration with the
following research groups:
- HOVON-Dutch-Belgian Cooperative Trial Group for
Hematology-Oncology
- Grupo Espanyol de Linfomas/Trasplante Autologo de Medula Osea
(GELTAMO)
- National Cancer Research Institute Lymphoma Clinical Studies
Group
- Nordic Lymphoma Group
- Polish Lymphoma Research Group
- The All Ireland Cooperative Oncology Research Group
About DLBCL
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), and
is an aggressive (fast-growing) lymphoma or cancer of the B-cells.1
DLBCL is the most common lymphoid malignancy in adults, accounting
for 30% of all NHL in the Western world.2 Approximately 38,000 new
cases of DLBCL occur annually in the US, Japan and five major
European markets.3
About Ofatumumab (Arzerra)
Ofatumumab--a human monoclonal antibody which targets an epitope
on the CD20 molecule encompassing parts of the small and large
extracellular loops--is not approved or licensed anywhere in the
world for the treatment of DLBCL.4
For the approved indications and 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/.
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/SGenmab 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(tm) (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:
Bernadette
King
+1 215 778
3027 (Philadelphia)
Anna
Padula +1
215 751
4271 (Philadelphia)
Melinda
Stubbee +1
919 483
2510 (North
Carolina)
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, Senior Vice President, Investor
Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62
60; E: r.gravesen@genmab.com
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).
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.
Registered in England & Wales: No.
3888792
Registered Office: 980 Great West Road
Brentford, Middlesex TW8 9GS
References 1 Lymphoma Research Foundation.
Diffuse Large B-Cell Lymphoma (DLBCL). Available at:
http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300153.
Copyrighted 2012. Accessed April 30, 2014. 2 Swerdlow SH, Campo E,
Harris NL, et al. WHO Classification of Tumours of Haematopoietic
and Lymphoid Tissues (4th ed). Lyon, France: IARC Press, 2008. 3
Datamonitor. Pipeline Insight: Lymphomas, Multiple Myeloma &
Myelodyplastic Syndromes. March 2010 4 Teeling et al, J
Immunol 2006; 177:362-371
Company Announcement no. 26 CVR no. 2102 3884
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