Aeterna Zentaris Says DSMB Recommends Continuation Of ZoptEC Phase 3 Trial

(RTTNews) - Aeterna Zentaris Inc. (AEZS, AEZ.TO) announced that the independent Data and Safety Monitoring Board or "DSMB" has recommended that the pivotal Phase 3 ZoptEC or Zoptarelin Doxorubicin in Endometrial Cancer study with zoptarelin doxorubicin in women with 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 3 trial at approximately 192 events. In April 2015, the DSMB made the same recommendation following its first pre-specified analysis on safety and futility at approximately 124 events. A final analysis of the data is expected at approximately 384 events.

The ZoptEC pivotal Phase 3 trial is a fully-recruited (over 500 patients), open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, to doxorubicin alone.

Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint. Secondary endpoints include progression-free survival, objective response-rate, and clinical benefit rate. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration.

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.