Summary: Phase III Pivotal study did not fulfill a criterion for early
stopping; Independent Data Monitoring Committee has recommended that the trial
should continue to enroll patients.
Copenhagen, Denmark; January 5, 2009 - Genmab A/S (OMX: GEN) announced today
that the interim survival analysis of the Phase III pivotal study investigating
zalutumumab (HuMax-EGFr(R)) in refractory head and neck cancer patients did not
fulfill a criterion for early stopping after half the trial has been completed.
An Independent Data Monitoring Committee (IDMC) has evaluated the interim
results and concluded that the benefit-risk profile of zalutumumab is
acceptable. The IDMC recommended that the trial should continue to enroll up to
a maximum of 273 patients and a final analysis performed.
As of today, 212 patients have been randomized and the final analysis will take
place once 231 deaths have occurred.
"We are pleased that this study will continue and are optimistic that the full
study results will show extended survival in patients with advanced head and
neck cancer," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial
The pivotal study will include a maximum of 273 patients with squamous cell
carcinoma of the head and neck (SCCHN) who are refractory to or intolerant of
standard platinum-based chemotherapy. Patients in the study will be randomized
into two treatment groups: zalutumumab in combination with best supportive care
or best supportive care alone. Patients treated with zalutumumab in combination
with best supportive care will receive an initial dose of 8mg/kg of zalutumumab,
followed by weekly infusions of a maintenance dose until disease progression.
The maintenance dose will be adjusted as necessary until the patient develops a
dose limiting skin rash, up to a maximum dose of 16 mg/kg of zalutumumab.
Disease status will be assessed every 8 weeks by CT scan or MRI according to
RECIST criteria until disease progression and patients will be followed for
survival.
The objective of the study is to evaluate the efficacy of zalutumumab in
combination with best supportive care as compared to best supportive care alone
in terms of overall survival. The primary endpoint in the study is overall
survival from randomization until death.
Conference Call
Genmab will hold a conference call to discuss these results today, January 5,
2009 at:
6:00 pm CET
5:00 pm GMT
12:00 pm EST
The conference call will be held in English.
The dial in numbers are as follows:
+1 877-856-1969 (in the US) and ask for the Genmab conference call
+1 719-325-4814 (outside the US) and ask for the Genmab conference call
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, development and manufacturing 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.
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. For a
further discussion of these risks, please refer to the section “Risk Management”
in Genmab's Annual Report, which is available on www.genmab.com. Genmab does
not undertake any obligation to update or revise forward looking statements in
this press release 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-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. 01/2009
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Genmab Announces Interim Results in Pivotal Study of Zalutumumab in Head and Neck Cancer
| Source: Genmab A/S
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