Aeterna Zentaris said that AEZS-108 is in a Phase 2 trial conducted in Europe by the German AGO Study Group (Study AGO-GYN5), in advanced ovarian and endometrial cancer, with final results expected by year-end.
In the trial, the patients were given a recommended dose of 267mg/m2 by intravenous infusion over 2 hours, with retreatment every 3 weeks, for up to 6 courses. Response rate (RECIST and/or GCIG criteria) was defined as primary endpoint. Secondary endpoints were safety, time-to-progression (TTP) and overall survival (OS).
Aeterna Zentaris treated 42 patients with platinum-resistant ovarian cancer. Efficacy included partial response in 5 patients (11.9%) and stable disease for more than 12 weeks in 11 patients (26.2%). Based on those data, a clinical benefit rate (CBR) of 38% can be estimated. Median time to progression (TTP) and overall survival (OS) were 3.5 months (104 days) and 15.6 months (475 days), respectively.
The result of the trial suggested that AEZS-108 was active and well tolerated in patients with heavily pre-treated platinum and taxane resistant ovarian cancer.
Prof Emons said: “The efficacy of AEZS-108 in our study was encouraging, considering that it only included patients resistant to prior platinum and taxane-based therapies.
“In these patients, a clinical benefit rate of 38% and particularly a median overall survival of over 15 months compare favourably with results for drugs such as topotecan and pegylated liposomal doxorubicin that are currently used in this setting. Furthermore, the safety profile of AEZS-108 was relatively benign with no unexpected findings and in particular, no cardiac toxicity.”
Juergen Engel, president and CEO of Aeterna Zentaris, said: “With these favourable results in refractory ovarian cancer patients, we are now looking forward to the data of our endometrial cancer study scheduled for the fourth quarter.”
The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held at McCormick Place in Chicago, by Gunter Emons, chairman of department of obstetrics and gynaecology at Georg-August University Gottingen, Germany.