A phase 3 study designed to evaluate zoptarelin doxorubicin for women with locally advanced recurrent or metastatic endometrial cancer did not achieve its primary endpoint, according to the drug’s manufacturer.
Zoptarelin doxorubicin (Zoptrex, Aeterna Zentaris) is a hybrid molecule composed of a synthetic peptide carrier and the chemotherapy agent doxorubicin.
The phase 3 randomized controlled ZoptEC trial compared the safety and efficacy of zoptarelin doxorubicin vs. doxorubicin alone in 512 patients with locally advanced, recurrent or metastatic endometrial cancer.
Patients received either 267 mg/m2 zoptarelin doxorubicin or 60 mg/m2 doxorubicin via IV every 3 weeks for up to nine cycles.
Median OS served as the primary endpoint. Secondary endpoints included PFS, objective response rate and clinical benefit rate.
Zoptarelin conferred no significant benefit in median OS (10.9 months vs. 10.8 months) or PFS.
Cardiac disorders occurred in eight patients treated with zoptarelin doxorubicin and nine patients who received doxorubicin alone.
“We are very disappointed with the outcome of the ZoptEC phase 3 clinical study,” David A. Dodd, president and CEO of Aeterna Zentaris, said in a company-issued press release. “Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project.”