Summary: Genmab initiates a Phase I/II study of zalutumumab in combination with
radiotherapy for the treatment of advanced head and neck cancer.
Copenhagen, Denmark; June 24, 2008 - Genmab A/S (OMX: GEN) announced today it
has initiated a Phase I/II study of zalutumumab (HuMax-EGFr™) in combination
with radiotherapy for the treatment of advanced head and neck cancer. The study
will include a maximum of 36 patients who are ineligible for platinum based
chemotherapy.
“Platinum based chemotherapy is currently considered to be the best available
standard treatment for advanced head and neck cancer. We hope zalutumumab may
some day provide a treatment option for patients who are in need of less toxic
therapies,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial
In the dose-escalation part of the study, 6 to 24 patients will be enrolled in
cohorts of 3 patients per dose level of zalutumumab. The dose level for each
successive cohort will be determined by the aggregate safety data observed in
the prior cohorts. When the maximum tolerated dose of zalutumumab is
established, an additional cohort of 12 patients will be enrolled and treated at
this level.
Patients in the study will receive 8 weekly infusions of zalutumumab with the
first cohort receiving an initial dose of 12 mg/kg of zalutumumab followed by 7
maintenance doses of 8 mg/kg of zalutumumab in addition to radiotherapy.
Patients will be evaluated at 4 weeks following the last dose of zalutumumab and
will be followed for a total of 2 years.
The objective of the study is to evaluate the safety of repeat dosing and
establish the maximum tolerated dose of zalutumumab in combination with
radiotherapy in patients with advanced head and neck cancer who are ineligible
for platinum based chemotherapy. The primary endpoint of the study is adverse
events.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using cutting-edge
antibody technology, Genmab's world class discovery, development and
manufacturing teams have created and developed an extensive pipeline of products
for potential treatment of a variety of diseases including cancer and autoimmune
disorders. As Genmab advances towards a commercial future, we remain committed
to our primary goal of improving 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.
This press release 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 product discovery
and development, 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. Genmab is
not under an obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Stock Exchange Release no. 31/2008
###
Genmab Initiates Study of Zalutumumab with Radiotherapy in Head and Neck Cancer
| Source: Genmab A/S
Recommended Reading
-
Company Announcement COPENHAGEN, Denmark; January 29, 2026 – Genmab A/S (Nasdaq: GMAB) announced today that the Board of Directors decided to grant 32,806 restricted stock units and 34,307 warrants...
Read More -
Company Announcement Net sales of DARZALEX® in 2025 totaled USD 14,351 millionGenmab receives royalties on worldwide net sales from Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.)...
Read More