DAHANCA Initiates Head and Neck Cancer Study with Genmab's HuMax-EGFr

Genmab A/S announced today the initiation of a Phase III study of HuMax-EGFr™ to treat head and neck cancer in cooperation with the Danish Head and Neck Cancer Group (DAHANCA)

COPENHAGEN, Denmark | September 13, 2007 |
Genmab A/S (OMX: GEN) announced today the initiation of a Phase III study of HuMax-EGFr™ (zalutumumab) to treat head and neck cancer in cooperation with the Danish Head and Neck Cancer Group (DAHANCA). The study will include approximately 600 previously untreated head and neck cancer patients to assess whether concomitant therapy with HuMax-EGFr can improve the efficacy of primary curative radiotherapy.

"We are excited for DAHANCA to begin the largest HuMax-EGFr trial to date," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope that HuMax-EGFr provides additional benefit to head and neck cancer patients receiving radiotherapy."

About the trial


Patients in the study will be randomized to treatment with radiotherapy or HuMax-EGFr plus radiotherapy. All patients will receive treatment with accelerated radiotherapy plus nimorazole and may also receive cisplatin chemotherapy. Patients receiving HuMax-EGFr will receive six weekly doses of 8 mg/kg of HuMax-EGFr. Patients will be followed for at least 5 years and will be clinically evaluated at months 2, 5, 8 and 12 after completion of treatment. Evaluations will continue every 4 months in the second year and every 6 months the third and fourth year and once a year thereafter.

The objective of the study is to determine the efficacy of HuMax-EGFr in combination with radiotherapy in treating patients with squamous cell carcinoma of the head and neck. The primary endpoint is loco-regional control and secondary endpoints are overall survival, disease free survival and acute and late side effects.

About cancers of the head and neck

Head and neck cancers may affect the mouth, nasal cavities, sinuses, larynx and pharynx. Most are squamous carcinomas but others include lymphoepithelioma and lymphoma. Head and neck cancers account for 3 % of all cancers in the U.S., with 40,000-60,000 cases diagnosed and 12,000 deaths annually. Worldwide incidence is about half a million with nearly 250,000 deaths.

SOURCE: GENMAB

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