Genmab Provides Update on Ofatumumab Phase III Head to Head Study in DLBCL
Genmab A/S
19.03.2012 08:03
Dissemination of a Adhoc News, transmitted by DGAP - a company of
EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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- Protocol amendment submitted to regulatory authorities
- Chemotherapy regimen to be focused
- Estimate for primary data readout moved forward
Copenhagen, Denmark; March 19, 2012 - Genmab A/S (OMX: GEN) announced today the
submission of a protocol amendment for the ofatumumab Phase III head-to-head
study in diffuse large B-cell lymphoma (DLBCL) to regulatory authorities.
According to the amended protocol all patients recruited in the study which
investigates ofatumumab plus chemotherapy versus rituximab plus chemotherapy in
relapsed or refractory DLBCL, will receive the same chemotherapy regimen
(DHAP). This change will revise underlying timing assumptions in the study and
could bring forward the primary endpoint analysis to early 2014.
'We look forward to discussing the changes with regulators ahead of potential
regulatory filings for ofatumumab in relapsed or refractory DLBCL that could
take place as early as the end of 2014,' said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
About the study
The study now includes 410 patients who are refractory to or have relapsed
following first line treatment with rituximab in combination with a
chemotherapy regimen containing anthracycline and are eligible for autologous
stem cell transplant (ASCT). Patients in the study will be randomized to
receive three cycles of either ofatumumab or rituximab in addition to DHAP
chemotherapy. After the third treatment cycle patients who obtain a complete
or partial response will receive high dose chemotherapy followed by ASCT. The
primary endpoint of the study is progression free survival.
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20
molecule encompassing parts of the small and large extracellular loops (Teeling
et al 2006). Ofatumumab is not approved in any country for treatment of
relapsed or refractory DLBCL. Ofatumumab is being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
In the United States and Europe, ofatumumab is indicated for the treatment of
patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and
alemtuzumab. The effectiveness of ofatumumab is based on the demonstration of
durable objective responses. No data demonstrate an improvement in
disease-related symptoms or increased survival. Ofatumumab can cause serious
infusion reactions, prolonged and severe cytopenias, Progressive Multifocal
Leukoencephalopathy (PML), including fatal PML, and Hepatitis B infection and
reactivation.
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's first marketed
antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future product
candidates. Partnering of 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.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communication
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
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(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr;
HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-Her2; HuMax(r)-cMet,
HuMax(r)-CD74, DuoBody(tm) and UniBody(r)are all trademarks of Genmab A/S. Arzerra(r) is
a trademark of GlaxoSmithKline.
Company Announcement no. 4
CVR no. 2102 3884
Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark
Click on, or paste the following link into your web browser, to view the associated documents
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=383380
News Source: NASDAQ OMX
19.03.2012 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genmab A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Genmab A/S
19.03.2012 08:03
Dissemination of a Adhoc News, transmitted by DGAP - a company of
EquityStory AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
- Protocol amendment submitted to regulatory authorities
- Chemotherapy regimen to be focused
- Estimate for primary data readout moved forward
Copenhagen, Denmark; March 19, 2012 - Genmab A/S (OMX: GEN) announced today the
submission of a protocol amendment for the ofatumumab Phase III head-to-head
study in diffuse large B-cell lymphoma (DLBCL) to regulatory authorities.
According to the amended protocol all patients recruited in the study which
investigates ofatumumab plus chemotherapy versus rituximab plus chemotherapy in
relapsed or refractory DLBCL, will receive the same chemotherapy regimen
(DHAP). This change will revise underlying timing assumptions in the study and
could bring forward the primary endpoint analysis to early 2014.
'We look forward to discussing the changes with regulators ahead of potential
regulatory filings for ofatumumab in relapsed or refractory DLBCL that could
take place as early as the end of 2014,' said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
About the study
The study now includes 410 patients who are refractory to or have relapsed
following first line treatment with rituximab in combination with a
chemotherapy regimen containing anthracycline and are eligible for autologous
stem cell transplant (ASCT). Patients in the study will be randomized to
receive three cycles of either ofatumumab or rituximab in addition to DHAP
chemotherapy. After the third treatment cycle patients who obtain a complete
or partial response will receive high dose chemotherapy followed by ASCT. The
primary endpoint of the study is progression free survival.
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20
molecule encompassing parts of the small and large extracellular loops (Teeling
et al 2006). Ofatumumab is not approved in any country for treatment of
relapsed or refractory DLBCL. Ofatumumab is being developed under a
co-development and commercialization agreement between Genmab and
GlaxoSmithKline.
In the United States and Europe, ofatumumab is indicated for the treatment of
patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and
alemtuzumab. The effectiveness of ofatumumab is based on the demonstration of
durable objective responses. No data demonstrate an improvement in
disease-related symptoms or increased survival. Ofatumumab can cause serious
infusion reactions, prolonged and severe cytopenias, Progressive Multifocal
Leukoencephalopathy (PML), including fatal PML, and Hepatitis B infection and
reactivation.
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's first marketed
antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future product
candidates. Partnering of 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.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communication
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
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(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr;
HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-Her2; HuMax(r)-cMet,
HuMax(r)-CD74, DuoBody(tm) and UniBody(r)are all trademarks of Genmab A/S. Arzerra(r) is
a trademark of GlaxoSmithKline.
Company Announcement no. 4
CVR no. 2102 3884
Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark
Click on, or paste the following link into your web browser, to view the associated documents
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=383380
News Source: NASDAQ OMX
19.03.2012 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genmab A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service
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