Genmab Announces Results from Zalutumumab Phase III Study of Refractory Head and Neck Cancer Patients

10-Mar-2010 - Denmark

Genmab A/S announced top-line results from a zalutumumab Phase III study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who failed standard platinum-based chemotherapy. Median overall survival in patients receiving zalutumumab in combination with best supportive care (BSC) was 6.7 months compared to 5.2 for BSC alone (p = 0.0648). Although this represented a 30% improvement (hazard ratio of 1.30), the result was not sufficient to demonstrate a statistically significant difference in overall survival, the primary endpoint of the study. However, patients in the zalutumumab arm did experience a 61% increase in progression free survival compared to patients in the BSC alone arm (p=0.0010).

An initial review of the data reveals that 28% of patients randomized to the BSC arm (n = 95) and 14% of patients in the zalutumumab arm (n = 191) received other anti-cancer therapies not permitted by the protocol. The median time to first use of other anti-cancer therapies was 79 days in the BSC arm compared to 170 days in the zalutumumab arm.

Zalutumumab was generally well tolerated by patients in the study. The safety profile observed for zalutumumab was as expected within this drug class in patients with SCCHN. Adverse events reported more frequently for patients in the zalutumumab plus BSC group were infusion related reactions, skin and nail disorders, electrolyte disturbances (hypomagnesemia and hypokalemia), gastrointestinal disorders (diarrhea grade 1-2), eye disorders, infections and headache. There were no unexpected safety findings. In this dose to rash study, the majority of patients (60%) received the highest dose of zalutumumab, 16 mg/kg.

“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,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.f

https://www.bionity.com/en/news/114625/genmab-announces-results-from-zalutumumab-phase-iii-study-of-refractory-head-and-neck-cancer-patients.html