Aeterna Zentaris gets DSMB green-lights to continue Phase III trial for zoptarelin doxorubicin to treat endometrial cancer

Aeterna Zentaris (Nasdaq: AEZS) on Tuesday said Data and Safety Monitoring Board (DSMB) has recommended the late stage trial for zoptarelin doxorubicin to treat advanced, recurrent or metastatic endometrial cancer, continue as planned.

The DSMB's decision follows completion of its pre‑specified second interim analysis on efficacy and safety for the ZoptEC Phase III trial at about 192 events, the company said.

David Dodd, chief executive of Aeterna Zentaris, said: "This positive second recommendation from the DSMB is an important milestone since it supports our continuation of the ZoptEC Phase III trial in endometrial cancer until its completion. The DSMB recommendation was based upon a comprehensive review of the data on efficacy and safety.  We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer.”