Genmab begins Ph III study of anticancer MAb

Denmark's Genmab AS, a biotechnology company focused on the development of human antibodies for use in serious diseases, says it has initiated a Phase III trial of HuMax-EGFr (zalutumumab) as a treatment for patients with incurable cancer of the head and neck.

The study is designed to enroll a maximum of 273 SCCHN patients who are refractory to or intolerant of standard platinum-based therapy, who are considered incurable by current standards. Those participating will be randomized to receive HuMax-EGFr in combination with the best supportive care, or best supportive care alone. Subjects in the MAb treated cohort will begin on an 8mg/kg dose of the drug, followed by weekly infusions of a maintenance dose until disease progression.

The firm added that the maintenance dosage will be adjusted as necessary until the patient develops a dose-limiting skin rash, up to a maximum of 16mg/kg. An assessment of disease status will be carried out every two months by CT scan or by the RECIST (Response Evaluation Criteria in Solid Tumors) methodology, until disease progression.