Phase 2 Study of AEZS-108 for Endometrial Cancer
Aeterna Zentaris announced final data from its Phase 2 study of AEZS-108 for the treatment of advanced endometrial cancer. Patients received AEZS-108 by IV infusion at a dose of 267mg/m2, once every three weeks. The primary endpoint was the response rate as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included safety, time-to-progression (TTP) and overall survival (OS).
Thirty-nine out of 43 patients were evaluated for efficacy by an independent response review. Data showed two complete responses (CR), 10 partial responses (PR) and 17 patients with disease stabilization (SD). Based on this data, the estimated overall response rate (ORR=CR+PR) was 30.8% and the clinical benefit rate (CBR=CR+PR+SD) was 74.4%. Responses in patients previously treated with chemotherapy included one CR, one PR and two SDs in eight of the patients with prior use of platinum/taxane regimens. Median TTP and OS were seven months and 13.7 months, respectively. Good tolerability of AEZS-108 was also reflected by a low rate of severe non-hematological possibly drug-related adverse events which included single cases each of nausea, diarrhea, fatigue, general health deterioration, creatinine elevation, and blood potassium decrease. No cardiac toxicity was reported.
AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and chemotherapy agent, doxorubicin. AEZS-108 is the first targeted cytotoxic IV drug that directs the chemotherapy agent specifically to luteinizing hormone releasing hormone (LHRH)-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue.
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