Genmab Presents Data From a Pivotal Trial of Zalutumumab Versus Best Supportive Care in Patients With Refractory Head and Neck C
June 07 2010 - 4:09PM
Summary: Data presented at ASCO from the first controlled study to
demonstrate that an EGFr-targeted antibody given as monotherapy
induces a clinically meaningful improvement in progression free
survival in patients with refractory head & neck cancer who
have failed platinum-based chemotherapy.
Copenhagen, Denmark; June 7, 2010 - Genmab A/S (Copenhagen:GEN)
announced today that data from the pivotal trial of zalutumumab in
refractory head and neck cancer patients will be presented today at
the 2010 American Society of Clinical Oncology (ASCO) Annual
Meeting, which will be held June 1-8 in Chicago, Illinois. This is
the first controlled study to demonstrate that an EGFr-targeted
antibody given as monotherapy induces a clinically meaningful
improvement in progression free survival in patients with
refractory head and neck cancer who have failed platinum-based
chemotherapy.
Dr. Jean-Pascal Machiels will present data from a pivotal Phase
III trial of zalutumumab in combination with best supportive care
(BSC) versus BSC alone in patients with non-curable squamous cell
carcinoma (SCCHN) of the head and neck who have failed standard
platinum-based chemotherapy (abstract number: LBA5506) today at
3:45 PM CDT. This research will also be presented at the 2010 Best
of ASCO San Francisco Meeting, July 16-17, 2010. The purpose of the
Best of ASCO meeting, according to their program announcement, is
to provide additional "accessibility to important scientific
research presented by respected members of the oncology community."
The full abstract may be viewed at www.asco.org.
"We are pleased that the data shows zalutumumab given as
monotherapy can provide a clinically meaningful improvement in
progression free survival for these very sick patients," said Lisa
N. Drakeman, Chief Executive Officer of Genmab. "We will continue
to review the results with our clinical advisors and the regulatory
authorities to determine next steps."
About the study
The pivotal, randomized multicenter trial compared zalutumumab
in combination with BSC to BSC alone in 286 patients with recurrent
or metastatic SCCHN who had previously failed at least one course
of standard platinum-based chemotherapy. Patients randomized to
zalutumumab in combination with BSC received an initial dose of 8
mg/kg of zalutumumab, followed by weekly administrations of
individually dose adjusted maintenance therapy of up to 16 mg/kg
until disease progression. Patients treated with BSC alone were
also allowed to receive methotrexate at a maximum weekly dose of 50
mg/m2. Disease status was assessed by CT scan or MRI every 8 weeks
and response evaluated according to RECIST criteria by an
Independent endpoints Review Committee. The primary endpoint in the
study was overall survival from randomization until death.
Analysis showed a 61% improvement in progression free survival
(PFS) was observed for patients in the zalutumumab plus BSC arm
(p=0.001). The six month PFS rate for patients in the zalutumumab
plus BSC arm was 20% compared to 7.3% for patients in the BSC alone
arm.
Although a median overall survival of 6.7 months was observed in
the zalutumumab group compared to 5.2 in the BSC group, this was
not statistically significant (p=0.065).
In addition, the objective response and disease control rates
for the patients in the zalutumumab arm were 6.3% and 48%
respectively, compared to 1.1% and 27% respectively for patients in
the BSC alone arm.
About zalutumumab
Zalutumumab is a novel, investigational, high-affinity, human
antibody that targets the Epidermal Growth Factor receptor (EGFr),
a molecule over-expressed on the surface of many cancer cells and
that is a well validated target. Zalutumumab is in development to
treat head and neck cancer and has received Fast Track designation
from the FDA for advanced, metastatic and/or unresectable SCCHN
that has progressed following standard platinum-based
chemotherapy.
Under the FDA Modernization Act of 1997, Fast Track designation
means that FDA will take such actions as are appropriate to
expedite the development and review of the application for approval
of such product. FDA may also evaluate for filing and commence
review of portions of an application for approval of a Fast Track
product under certain conditions.
About Genmab A/S
Genmab is a leading international biotechnology company focused
on developing fully human antibody therapeutics for the potential
treatment of cancer. Genmab's world class discovery and development
teams are using cutting-edge technology to create and develop
products to address unmet medical needs. Our primary goal is to
improve the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
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Stock Exchange Release no. 22/2010
CONTACT: Genmab A/S
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+45 33 44 77 30,
Mobile: +45 25 27 47 13
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