GSK and Genmab Announce Topline Results from a Pivotal Head to Head Study of Ofatumumab in Combination With Chemotherapy vs

GSK and Genmab Announce Topline Results from a Pivotal Head to Head Study of
Ofatumumab in Combination With Chemotherapy vs Rituximab in Combination with
Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-cell

Company Announcement

  *No statistically significant difference in progression free survival in
    ofatumumab plus chemotherapy treatment arm compared to rituximab plus
  *Detailed data will be presented at an upcoming medical conference

LONDON and COPENHAGEN, Denmark, May 19, 2014 (GLOBE NEWSWIRE) --
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 >=3AEs, 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

The ORCHARRD study was conducted in collaboration with the following research

  *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


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 For the
approved indications and European Union (EU) Summary of Product
Characteristics (SPC) visit

Ofatumumab is being developed under a co-development and collaboration
agreement between Genmab and GSK. Arzerra is a trademark of the GSK group of

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

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

GSK enquiries:
UK Media enquiries: David Mawdsley+44 (0) 20 8047

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

Padula+1 215 751 4271(Philadelphia)

Melinda Stubbee+1
919 483 2510(North Carolina)

Collins+1 919 483 2527(North Carolina)

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)

Curry+ 1 215 751 5419(Philadelphia)

Davies+44 (0) 20 8047 5503(London)

Dodwell+44 (0) 20 8047 2406(London)

McLaughlin+1 215 751 7002(Philadelphia)

Singah+44 (0) 20 8047 2248(London)

Genmab enquiries:

Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
T: +45 33 44 77 20; M: +45 25 12 62 60; E:

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 . 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

^1 Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma (DLBCL).
Available at:
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 Immunol2006; 177:362-371

Company Announcement no. 26
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
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