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Zalutumumab is a fully human EGFr monoclonal antibody that has demonstrated clinical benefit in refractory head and neck cancer. Zalutumumab has the potential to be developed for large solid tumor markets including head and neck, colorectal, non small cell lung, pancreatic, breast cancer, prostate, gastric and other cancers. Genmab is no longer actively developing zalutumumab and the antibody is available for licensing from Genmab.

Zalutumumab Highlights
  • Zalutumumab has shown a clinical benefit.
  • Zalutumumab is directed to EGFr, a proven oncology target.
  • Zalutumumab has the most promising overall mechanisms of action in its class.
  • In clinical studies, zalutumumab has been dosed in a personalized way to maximize exposure for each patient.
  • Zalutumumab is not expected to produce a hypersensitivity reaction as seen with cetuximab.
  • The efficacy of zalutumumab is not changed by EGFr mutations.
  • Zalutumumab has patent protection until 2014.

Clinical Benefit
Genmab has conducted a Phase III pivotal study of zalutumumab in patients with recurrent or metastatic SCCHN who failed standard platinum-based chemotherapy. The study included two treatment groups – zalutumumab plus best supportive care (BSC) versus BSC alone. Patients received individualized dosing of zalutumumab until rash, a probable marker for tumor saturation and survival. The primary endpoint of the study was overall survival and the data were analyzed after 231 deaths. A total of 286 patients were recruited in the study.

The study failed to meet its primary endpoint, but did demonstrate a 61% increase in progression free survival compared to patients on best supportive care alone (p=0.0010). Median overall survival in the study was 6.7 for patients receiving zalutumumab versus 5.2 months in the BSC group; a 30% increase in overall survival in the study, and a clinically meaningful result in this patient population for whom no other treatment options are proven to prolong survival. Zalutumumab also controlled the patients’ disease better than BSC (48% vs. 27%, p=0.0013).

According to the study protocol, patients receiving zalutumumab were not permitted to receive treatment with methotrexate, while it was permitted and used to treat 78% of patients in the BSC group. Recent data suggest that methotrexate may be an active treatment in head and neck cancer, which was unknown at the time the zalutumumab study was designed.

There were no unexpected safety findings in the trial. The most common adverse events were infusion related reaction, skin and nail disorders, electrolyte disturbances, gastrointestinal disorders, eye disorders, infections and headache. Final data from the study is expected in 2012.

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