Firm believes Zalutumumab could be filed for approval in Europe based on available clinical data.
Genmab is putting the dust-covers on its Phase III-stage squamous cell carcinoma of the head and neck (SCCHN) antibody candidate zalutumumab until a development and commercialization partner is found. The firm says an extensive search for a potential partner during the first half of this year has failed, and it can’t afford to invest further in development of the antibody on its own.
“We have always been focused on ending our investment in zalutumumab so that we can concentrate our resources to progress other high-value programs in our pipeline,” remarks Jan van de Winkel, Ph.D., CEO. “The product has shown good results in our clinical studies without any serious adverse effects, and I believe it has therapeutic potential. However, we were committed to taking a decision on the future of the product by the end of June and therefore we will now shelve Zalutumumab but make it available for partnership should the opportunity arise.”
Zalutumumab is a fully human EGFR mAb that has initially been developed for treating refractory SCCHN but has potential utility against other solid tumor types that overexpress EGFR, Genmab states. The drug received fast track designation from the FDA for the treatment of advanced, metastatic, and/or unresectable SCCHN that has progressed following standard platinum-based chemotherapy.
Data from a completed pivotal trial in refractory SCCHN patients who had failed standard platinum-based chemotherapy was presented in June 2010. The firm says although the study failed to meet its primary overall survival endpoint, it showed that SCCHN patients treated with the antibody demonstrated a 61% increase in progression free survival compared with those receiving best supportive care.
In addition, the objective response and disease control rates for patients in the zalutumumab arm were 6.3% and 48% respectively compared to 1.1% and 27% respectively for patients in the best supportive care arm. The clinical trial program for zalutumumab in SCCHN includes a Phase III front-line study, a Phase II refractory study, and two Phase I/II studies.
In October 2010, Genmab said that as a result of preliminary discussions with the European regulatory authorities and with FDA, it believed a marketing authorization application for zalutumumab in Europe could be pursued based on data from the Phase III study in patients with recurrent or metastatic SCCHN who have failed standard platinum-based therapy, but additional clinical study data would be required prior to submitting a regulatory application in the U.S.