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Aeterna Zentaris Presents Positive Phase 2 Efficacy and Safety Data for AEZS-108 in Advanced Endometrial Cancer at ENA Meeting in Berlin, Germany
Date:11/18/2010

8, the Company's targeted cytotoxic drug in which doxorubicin, a well known chemotherapeutic agent, is linked to [D-Lys(6)]-luteinizing hormone releasing hormone (LHRH), in women with histologically confirmed LHRH-R positive advanced (FIGO III or IV) or recurrent endometrial cancer. Patients received a recommended dose of 267 mg/m2 by intravenous infusion over 2 hours, with retreatment every 3 weeks, for up to 6 courses. Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) was defined as primary endpoint. Secondary endpoints were safety, time-to-progression (TTP) and overall survival (OS). Results In all, 44 patients entered the study. Of these, 1 patient was withdrawn prior to start of treatment and 2 patients entered as replacement for patients withdrawn for reasons other than progressive disease. Of 43 patients treated with AEZS-108, 39 were evaluable for efficacy. Responses confirmed by independent review included 2 patients with complete response (CR; 5.1%), 10 patients with partial response (PR; 25.6%), and 17 patients with stable disease (SD; 43.6%). Based on those data, an Overall Response Rate (ORR = CR+PR) of 30.8 % and a Clinical Benefit Rate (CBR = CR+PR+SD) of 74.4% can be estimated. Responses were also achieved in patients with prior chemotherapy, 1 CR, 1 PR and 2 SDs in 8 of the patients pre-treated with platinum/taxane regimens. Median time to progression (TTP) and overall survival (OS) were 7 months (30 weeks) and 14.3 months (62 weeks), respectively.

Overall, tolerability of AEZS-108 was good and commonly allowed retreatment as scheduled. Only one patient (2%) had a dose reduction, and 17 (8%) courses were given with a delay, including also 11 cases in which delay was not related to toxicity. Severe (Grade 3 or 4) toxicity was mainly restricted to rapidly reversible hematologic toxicity (leukopenia/neutropenia) associated with fever in 1 case only, a patient who had been treated only 3 weeks after a surgery. G
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SOURCE AETERNA ZENTARIS INC.
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