Genmab Presents Data from a Pivotal Trial of Zalutumumab in Patients with Refractory Head and Neck Cancer
Genmab A/S announced that data from the pivotal trial of zalutumumab in refractory head and neck cancer patients is presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in progression free survival in patients with refractory head and neck cancer who have failed platinum-based chemotherapy.
Dr. Jean-Pascal Machiels presented data from a pivotal Phase III trial of zalutumumab in combination with best supportive care (BSC) versus BSC alone in patients with non-curable squamous cell carcinoma (SCCHN) of the head and neck who have failed standard platinum-based chemotherapy.
“We are pleased that the data shows zalutumumab given as monotherapy can provide a clinically meaningful improvement in progression free survival for these very sick patients,” said Lisa N. Drakeman, Chief Executive Officer of Genmab. “We will continue to review the results with our clinical advisors and the regulatory authorities to determine next steps.”
The pivotal, randomized multicenter trial compared zalutumumab in combination with BSC to BSC alone in 286 patients with recurrent or metastatic SCCHN who had previously failed at least one course of standard platinum-based chemotherapy. Patients randomized to zalutumumab in combination with BSC received an initial dose of 8 mg/kg of zalutumumab, followed by weekly administrations of individually dose adjusted maintenance therapy of up to 16 mg/kg until disease progression. Patients treated with BSC alone were also allowed to receive methotrexate at a maximum weekly dose of 50 mg/m2. Disease status was assessed by CT scan or MRI every 8 weeks and response evaluated according to RECIST criteria by an Independent endpoints Review Committee. The primary endpoint in the study was overall survival from randomization until death.
Analysis showed a 61% improvement in progression free survival (PFS) was observed for patients in the zalutumumab plus BSC arm (p=0.001). The six month PFS rate for patients in the zalutumumab plus BSC arm was 20% compared to 7.3% for patients in the BSC alone arm. Although a median overall survival of 6.7 months was observed in the zalutumumab group compared to 5.2 in the BSC group, this was not statistically significant (p=0.065). In addition, the objective response and disease control rates for the patients in the zalutumumab arm were 6.3% and 48% respectively, compared to 1.1% and 27% respectively for patients in the BSC alone arm.
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