Genmab announced today it has completed enrollment of 273 patients in the zalutumumab pivotal Phase III study in refractory head and neck cancer. Genmab expects to report final results from the study by the end of 2009
Gopenhagen, Denmark | June 10, 2009 | Genmab A/S (OMX: GEN) announced today it has completed enrollment of 273 patients in the zalutumumab pivotal Phase III study in refractory head and neck cancer. Genmab expects to report final results from the study by the end of 2009.
About the trial
The pivotal study includes patients with squamous cell carcinoma of the head and neck (SCCHN) who are refractory to or intolerant of standard platinum-based chemotherapy. Patients in the study are randomized into two treatment groups: zalutumumab in combination with best supportive care or best supportive care alone. Patients treated with zalutumumab in combination with best supportive care receive an initial dose of 8mg/kg of zalutumumab, followed by weekly infusions of a maintenance dose until disease progression. The maintenance dose is adjusted as necessary until the patient develops a dose limiting skin rash, up to a maximum dose of 16 mg/kg of zalutumumab. 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 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.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology, visit www.genmab.com.
SOURCE: Genmab
Post Views: 73
Genmab announced today it has completed enrollment of 273 patients in the zalutumumab pivotal Phase III study in refractory head and neck cancer. Genmab expects to report final results from the study by the end of 2009
Gopenhagen, Denmark | June 10, 2009 | Genmab A/S (OMX: GEN) announced today it has completed enrollment of 273 patients in the zalutumumab pivotal Phase III study in refractory head and neck cancer. Genmab expects to report final results from the study by the end of 2009.
About the trial
The pivotal study includes patients with squamous cell carcinoma of the head and neck (SCCHN) who are refractory to or intolerant of standard platinum-based chemotherapy. Patients in the study are randomized into two treatment groups: zalutumumab in combination with best supportive care or best supportive care alone. Patients treated with zalutumumab in combination with best supportive care receive an initial dose of 8mg/kg of zalutumumab, followed by weekly infusions of a maintenance dose until disease progression. The maintenance dose is adjusted as necessary until the patient develops a dose limiting skin rash, up to a maximum dose of 16 mg/kg of zalutumumab. 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 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.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology, visit www.genmab.com.
SOURCE: Genmab
Post Views: 73
