Genmab A/S
8 Mar, 2010 13:37 CET
Genmab A/S Company Announcement Genmab Announces Results from Zalutumumab Phase III Study of Refractory Head and Neck Cancer Patients
Summary: Genmab announces top-line results from a study of zalutumumab inrefractory head and neck cancer patients who failed platinum basedchemotherapy.
Copenhagen, Denmark; March 08, 2010 - Genmab A/S (OMX: GEN) announced todaytop-line results from a zalutumumab Phase III study in patients with recurrentor 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 theBSC 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 inpatients with SCCHN. Adverse events reported more frequently for patients in the zalutumumab plus BSC group were infusion related reactions, skin and naildisorders, 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, 16mg/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 LisaN. Drakeman, Ph.D., Chief Executive Officer of Genmab.
The results will be submitted for presentation at the 2010 American Society of Clinical Oncology Annual Meeting in Chicago in June. About the study The pivotal, randomized multicenter trial compared zalutumumab in combinationwith BSC to BSC alone in 286 patients with recurrent or metastatic SCCHN whohad previously failed at least one course of standard platinum-basedchemotherapy. Patients randomized to zalutumumab in combination with BSC received an initial dose of 8mg/kg of zalutumumab, followed by weekly administrations of individually dose adjusted maintenance therapy of up to 16mg/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 evaluatedaccording to RECIST criteria by an Independent endpoints Review Committee. Theprimary endpoint in the study was overall survival from randomization untildeath.
About zalutumumab Zalutumumab is a novel, investigational, high-affinity, human antibody thattargets the Epidermal Growth Factor receptor (EGFr), a molecule overexpressed on the surface of many cancer cells and that is a well validated target. Zalutumumab is in development to treat head and neck cancer and has receivedFast Track designation from the FDA for advanced, metastatic and/orunresectable SCCHN that has progressed following standard platinum-basedchemotherapy. Under the FDA Modernization Act of 1997, Fast Track designation means that FDAwill take such actions as are appropriate to expedite the development andreview of the application for approval of such product. FDA may also evaluatefor filing and commence review of portions of an application for approval of aFast Track product under certain conditions.
Als ik dit zorgvuldig lees, hebben veel patiënten in deze steekproef baat gehad bij dit middel, hoewel het resultaat statistisch gezien niet significant is. Dat kan te maken hebben met de beperkte steekproef. Om op grond daarvan nog een keer 20% van de koers af te waarderen, lijkt mij een overreactie. Uiteraard is dit op zich een teleurstelling, maar bij dit niveau blijf ik beslist zitten.