A phase 3 clinical study of Aeterna Zentaris' Zoptrex (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer failed to achieve its primary endpoint.
It failed to demonstrate a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with doxorubicin.
Zoptarelin doxorubicin is a hybrid molecule that includes synthetic peptide carrier and chemotherapy agent doxorubicin.
The ZoptEC trial, which recruited 512 patients, is an open-label and randomized-controlled study that compared efficacy and safety of zoptarelin doxorubicin against doxorubicin alone.
The company had centrally randomized patients in a 1:1 ratio to secure either Zoptrex (267 mg/m2) or doxorubicin (60 mg/m2) intravenously for every three weeks with nine cycles.
Response has been assessed every three cycles during treatment, and then, every 12 weeks until progression.
All patients have been followed for survival as the primary efficacy endpoint, while secondary endpoints comprised of progression-free survival, objective response-rate, and clinical benefit rate.
Aeterna Zentaris chief scientific officer Dr Richard Sachse said: “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 3 clinical study did not meet its primary endpoint.”
Aeterna Zentaris president and CEO David Dodd said: “We are very disappointed with the outcome of the ZoptEC phase 3 clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex with respect to any other indications.”
Image: Aeterna Zentaris’ Zoptrex has failed to meet its primary endpoint in a phase III trial. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.