A late stage clinical study of Aeterna Zentaris’ Zoptrex in women with locally advanced, recurrent or metastatic endometrial cancer has failed to meet its primary endpoint of demonstrating a statistically significant increase in survival in patients taking the drug.
The median overall survival period for those treated with Zoptrex (zoptarelin doxorubicin) was 10.9 months compared to 10.8 months for patients treated with doxorubicin, which was not significantly different.
Zoptrex also performed no better than the comparator drug with respect to the secondary efficacy endpoints, with median progression-free survival identical across both treatment groups, for example.
“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,” said Dr Richard Sachse, the firm’s chief scientific officer.
“We are very disappointed with the outcome of the ZoptEC Phase III clinical study,” added president and chief executive David Dodd. “Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex with respect to any other indications.”
London, UK-based co-development partner Ergomed conducted the clinical trial in more than 100 study sites globally.
The firm said it contributed to the costs of the trial in return for a share in the revenues generated from the product’s commmercialisation, but despite its failure, has already received a portion of upfront payments from several license agreements entered into by Aeterna Zentaris in the important markets of China, Israel, Taiwan and Southeast Asia as well as Australia and New Zealand.