Genmab A/S has initiated a phase III pivotal study with HuMax-EGFr (zalutumumab) to treat patients with head and neck cancer that is considered incurable with standard treatment.

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.

"We are eager to begin the HuMax-EGFr pivotal study and are looking forward to starting treatment of these very sick head and neck cancer patients with the aim of increasing their life expectancy," said Lisa N. Drakeman, Ph.D., chief executive officer.

Patients in the study 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 8mg/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 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 HuMax-EGFr 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.