GENMAB BEGINS STUDY OF TREATMENT FOR HEAD, NECK CANCER

Genmab announced it has initiated a Phase III trial with HuMax- EGFr (zalutumumab) to treat patients with head and neck cancer that is considered incurable with standard treatment. The objective of the study is to evaluate the efficacy of HuMax-EGFr in combination with best supportive care compared with best supportive care alone in terms of overall survival. The primary endpoint in the study is overall survival.

The trial will enroll a maximum of 273 patients with squamous-cell carcinoma of the head and neck who are refractory to or intolerant of standard platinum-based chemotherapy. Patients will be randomized into two treatment groups: HuMax-EGFr in combination with best supportive care or best supportive care alone. Patients treated with HuMax-EGFr in combination with best supportive care will receive an initial dose of 8 mg/kg of HuMax-EGFr, 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 HuMax-EGFr. Disease status will be assessed every eight weeks by CT scan or MRI according to RECIST criteria until disease progression, and patients will be followed for the duration of survival.