Genmab Announces Results From Zalutumumab Phase III Study of Refractory Head and Neck Cancer Patients
08 March 2010 - 4:52PM
Summary: Genmab announces top-line results from a study of
zalutumumab in refractory head and neck cancer patients who failed
platinum-based chemotherapy.
Genmab A/S (Copenhagen: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 multi-center 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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