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Mar 8, 2010

Genmab to Review Clinical Plans for Head and Neck Cancer Candidate after Mixed Results from Phase III Trial

  • Genmab is reporting that Phase III results of its antibody for head and neck cancer, zalutumumab, showed that the treatment did not increase overall survival enough for it to be statistically significant but did significantly boost progression-free survival. The company says that it is evaluating its development program in this indication in light of this data.

    Zalutumumab is a human antibody targeting the epidermal growth factor receptor. The Phase III trial evaluated the treatment in 286 patients with recurrent or metastatic squamous cell carcinoma of the head and neck who failed standard platinum-based chemotherapy. Patients were randomized to receive either zalubumuab in combination with best supportive care (BSC) or BSC alone.

    Data showed that median overall survival in the zalutumumab plus BSC group was 6.7 months compared with 5.2 months for the BSC-only group. Genmab points out that although this represented a 30% improvement, the increase was not sufficient to demonstrate a statistically significant difference in survival. However, patients in the zalutumumab cohort did demonstrate a 61% increase in progression-free survival compared with those in the BSC-only arm.

    “The progression-free survival data indicates that zalutumumab can provide a benefit to these cancer patients, and we will review with our clinical advisors and the regulatory agencies how to best proceed with this product,” says Lisa N. Drakeman, Ph.D., Genmab CEO.

    Zalutumumab is also undergoing Phase I/II trials as a treatment for advanced head and neck cancer either in combination with chemo-radiation or in combination with radiotherapy in patients who are ineligible for platinum-based chemotherapy.  

     



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