Genmab begins HuMax-EGFr pivotal study in head and neck cancer

By E. Janene Geiss

Philadelphia, Sept. 14 - Genmab A/S said Thursday it has begun a phase 3 pivotal study with HuMax-EGFr (zalutumumab) to treat patients with head and neck cancer that is considered incurable with standard treatment.

The study will include 273 patients with squamous cell carcinoma of the head and neck who are refractory to or intolerant of standard platinum-based chemotherapy, the Copenhagen-based biopharmaceutical company said in a news release.

Patients in the study will be randomized into two treatment groups: HuMax-EGFr in combination with best supportive care or best supportive care alone. 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 survival.

The objective of the study is to evaluate the efficacy of HuMax-EGFr in terms of overall survival. The primary endpoint in the study is overall survival from randomization until death.

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