Genmab starts HuMax-EGFr combination study

Genmab A/S has announced it has initiated a Phase II study of HuMax-EGFr (zalutumumab) in combination with chemo-radiation to treat non small cell lung cancer (NSCLC).

The study will include a maximum of 270 previously untreated patients with advanced NSCLC.

"We are excited to expand the HuMax-EGFr program into this new indication and hope that it may some day prove to be an effective treatment for lung cancer patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

This open label study consists of two parts. Part 1 will include at least 24 patients divided into two sequential treatment groups. Patients in Group A will receive 2 cycles of induction chemotherapy in combination with weekly fixed doses of 8 mg/kg of HuMax-EGFr followed by 7 weekly 8 mg/kg doses of HuMax-EGFr in combination with radiotherapy. Pending satisfactory evaluation of safety data from Group A, patients in Group B will receive 2 cycles of induction chemotherapy in combination with HuMax-EGFr at individually titrated doses up to 16 mg/kg, based on the degree of skin rash the patient develops.

This will be followed by 7 weekly doses of HuMax-EGFr in combination with chemo-radiation.

Safety data from Part 1 of the trial will be evaluated to determine if it is safe to begin Part 2. There will be two treatment groups in Part 2 of the study. Patients will receive either 2 cycles of induction chemotherapy in combination with weekly doses of up to 16 mg/kg of HuMax-EGFr followed by 7 weekly doses of HuMax-EGFr in combination with chemo-radiation or 2 cycles of induction chemotherapy followed by chemo-radiation alone.

In both parts of the study, patients will be evaluated every 3 months until disease progression and every 4 weeks thereafter until death in accordance with the general methodology of trials in cancer patients.

The objective of the study is to evaluate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation versus chemo-radiation alone in the treatment of advanced NSCLC. The primary endpoint of the study is progression free survival from randomization until disease progression or death.

NSCLC is the leading cause of cancer deaths in both men and women, with approximately 172,000 patients being diagnosed annually in the US. Almost 25% of newly diagnosed patients will have advanced (stage IIIA or IIIB) disease for which effective treatment options are few.

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