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.
The objective of the study is to evaluate the efficacy of HuMax-EGFr (zalutumumab) 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.
“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 Drakeman, CEO of Genmab.