Genmab Announces Results from Zalutumumab Phase III Study of Refractory Head and Neck Cancer Patients

Summary: Genmab announces top-line results from a study of zalutumumab in
refractory head and neck cancer patients who failed platinum based
chemotherapy. 

Copenhagen, Denmark; March 08, 2010 - Genmab A/S (OMX: GEN) announced today
top-line results from a zalutumumab Phase III study in patients with recurrent
or metastatic squamous cell carcinoma of the head and neck (SCCHN) who failed
standard platinum-based chemotherapy. Median overall survival in patients
receiving zalutumumab in combination with best supportive care (BSC) was 6.7
months compared to 5.2 for BSC alone (p = 0.0648). Although this represented a
30% improvement (hazard ratio of 1.30), the result was not sufficient to
demonstrate a statistically significant difference in overall survival, the
primary endpoint of the study. However, patients in the zalutumumab arm did
experience a 61% increase in progression free survival compared to patients in
the BSC alone arm (p=0.0010). 

An initial review of the data reveals that 28% of patients randomized to the
BSC arm (n = 95) and 14% of patients in the zalutumumab arm (n = 191) received
other anti-cancer therapies not permitted by the protocol. The median time to
first use of other anti-cancer therapies was 79 days in the BSC arm compared to
170 days in the zalutumumab arm. 

Zalutumumab was generally well tolerated by patients in the study. The safety
profile observed for zalutumumab was as expected within this drug class in
patients with SCCHN. Adverse events reported more frequently for patients in
the zalutumumab plus BSC group were infusion related reactions, skin and nail
disorders, electrolyte disturbances (hypomagnesemia and hypokalemia),
gastrointestinal disorders (diarrhea grade 1-2), eye disorders, infections and
headache. There were no unexpected safety findings. In this dose to rash study,
the majority of patients (60%) received the highest dose of zalutumumab, 16
mg/kg. 

“The progression free survival data indicates that zalutumumab can provide a
benefit to these cancer patients and we will review with our clinical advisors
and the regulatory agencies how to best proceed with this product,” said Lisa
N. Drakeman, Ph.D., Chief Executive Officer of Genmab. 

The results will be submitted for presentation at the 2010 American Society of
Clinical Oncology Annual Meeting in Chicago in June. 

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 8mg/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. 

About zalutumumab
Zalutumumab is a novel, investigational, high-affinity, human antibody that
targets the Epidermal Growth Factor receptor (EGFr), a molecule overexpressed
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. 

Conference Call
Genmab will hold a conference call to discuss today's news on March 08, 2010 at

3:30 PM CET
2:30 PM GMT
9:30 AM EST

The conference call will be held in English.

The dial in numbers are as follows:
+1  877-941-6079 (in the US) 
+1 480-629-9779 (outside the US)

Please provide conference ID number 4259908

To listen to a live webcast of the call please visit www.genmab.com.

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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Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com 
 
Stock Exchange Release no. 07/2010

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