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Genmab Initiates HuMax-EGFr Combination Study in Non


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Small Cell Lung Cancer

http://www.prnewswire.com/cgi-bin/stori ... 353&EDATE=

COPENHAGEN, Denmark, April 12 /PRNewswire-FirstCall/ -- Genmab A/S

(CSE: GEN) announced today it has initiated a Phase II study of

HuMax-EGFr (zalutumumab) in combination with chemo-radiation to treat

non small cell lung cancer (NSCLC). The study will include a maximum of 270

previously untreated patients with advanced NSCLC.

"We are excited to expand the HuMax-EGFr program into this new

indication and hope that it may some day prove to be an effective treatment

for lung cancer patients," said Lisa N. Drakeman, Ph.D., Chief Executive

Officer of Genmab.

About the trial

This open label study consists of two parts. Part 1 will include at

least 24 patients divided into two sequential treatment groups. Patients in

Group A will receive 2 cycles of induction chemotherapy in combination with

weekly fixed doses of 8 mg/kg of HuMax-EGFr followed by 7 weekly 8 mg/kg

doses of HuMax-EGFr in combination with radiotherapy. Pending satisfactory

evaluation of safety data from Group A, patients in Group B will receive 2

cycles of induction chemotherapy in combination with HuMax-EGFr at

individually titrated doses up to 16 mg/kg, based on the degree of skin

rash the patient develops.

This will be followed by 7 weekly doses of HuMax-EGFr in combination

with chemo-radiation.

Safety data from Part 1 of the trial will be evaluated to determine if

it is safe to begin Part 2. There will be two treatment groups in Part 2 of

the study. Patients will receive either 2 cycles of induction chemotherapy

in combination with weekly doses of up to 16 mg/kg of HuMax-EGFr followed

by 7 weekly doses of HuMax-EGFr in combination with chemo-radiation or 2

cycles of induction chemotherapy followed by chemo-radiation alone.

In both parts of the study, patients will be evaluated every 3 months

until disease progression and every 4 weeks thereafter until death in

accordance with the general methodology of trials in cancer patients.

The objective of the study is to evaluate the safety and efficacy of

HuMax-EGFr in combination with chemo-radiation versus chemo-radiation alone

in the treatment of advanced NSCLC. The primary endpoint of the study is

progression free survival from randomization until disease progression or

death.

About Non Small Cell Lung Cancer

NSCLC is the leading cause of cancer deaths in both men and women, with

approximately 172,000 patients being diagnosed annually in the US. Almost

25% of newly diagnosed patients will have advanced (stage IIIA or IIIB)

disease for which effective treatment options are few.

About Genmab A/S

Genmab A/S is a biotechnology company that creates and develops human

antibodies for the treatment of life-threatening and debilitating diseases.

Genmab has numerous products in development to treat cancer, infectious

disease, rheumatoid arthritis and other inflammatory conditions, and

intends to continue assembling a broad portfolio of new therapeutic

products. At present, Genmab has multiple partnerships to gain access to

disease targets and develop novel human antibodies including agreements

with Roche and Amgen. A broad alliance provides Genmab with access to

Medarex, Inc.'s array of proprietary technologies, including the UltiMAb®

platform for the rapid creation and development of human antibodies to

virtually any disease target. In addition, Genmab has developed

UniBody, a new proprietary technology that creates a stable, smaller

antibody format. Genmab has operations in Europe and the US. For more

information about Genmab, visit http://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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD4®; HuMax-

EGFr; HuMax-Inflam; HuMax-CD20; HuMax-TAC; HuMax-HepC,

HuMax-CD38; HuMax-ZP3; and UniBody are all trademarks of Genmab

A/S.

UltiMAb® is a trademark of Medarex, Inc.

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