Zoptrex (zoptarelin doxorubicin) fails to meet primary endpoint in endometrial cancer- Aeterna Zentaris

Aeterna Zentaris announced that the ZoptEC Phase III clinical study of Zoptrex (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with doxorubicin. The median overall survival period for patients treated with Zoptrex was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase III clinical study did not meet its primary endpoint.

In addition, Zoptrex generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar � eight in the Zoptrex arm and nine in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval.