In the trial, patients received a recommended dose of 267mg/m2 by intravenous infusion over 2 hours, with retreatment every 3 weeks, for up to 6 courses.
Aeterna Zentaris said that response rate per Response Evaluation Criteria in Solid Tumors (RECIST) was defined as primary endpoint while the secondary endpoints were safety, time-to-progression (TTP) and overall survival (OS).
Department of Obstetrics & Gynaecology Georg-August University Gottingen chairman Gunter Emons said that the safety and efficacy of AEZS-108 in their study on advanced endometrial cancer was very encouraging.
"We must keep in mind that we used AEZS-108 as a single agent treatment only, and still achieved good rates of objective response and disease stabilisation," Emons said.
"Importantly from the patients’ point of view, overall survival was similar to what has been reported with more aggressive and less well tolerated combination chemotherapy regimens."
Aeterna Zentaris president and CEO Juergen Engel said that
these exciting positive results in endometrial cancer along with positive data for ovarian cancer disclosed earlier this year, reaffirm AEZS-108’s potential as a new targeted approach for the treatment of cancer.
"We now look forward to the further late-stage development of AEZS-108 for the benefit of women battling gynaecological cancers," Engel said.