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November 29, 2010
Aeterna Zentaris released positive results from a phase II trial of AEZS-108 for the treatment of endometrial cancer. This trial enrolled 44 subjects with histologically confirmed LHRH-R positive advanced or recurrent endometrial cancer. AEZS-108 was administered at a recommended dose of 267 mg/m2 by intravenous infusion over two hours, with retreatment every three weeks, for up to six courses. The primary endpoint was response rate per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Of 43 subjects treated with AEZS-108, 39 were evaluable for efficacy. Responses confirmed included two subjects with complete response (CR; 5.1%), ten subjects with partial response (PR; 25.6%), and 17 with stable disease (SD; 43.6%). Based on those data, the Overall Response Rate was 30.8 % and the Clinical Benefit Rate was 74.4%. The treatment was well tolerated.
November 1, 2010
Ariad Pharmaceuticals and Merck reported positive interim results from a phase II trial of oral ridaforolimus for endometrial cancer. This randomized, open-label, active-control multicenter study has enrolled 114 female subjects with metastatic or recurrent endometrial cancer. The subjects received oral ridaforolimus, oral progestin or chemotherapy. The primary endpoint is progression free survival (PFS) determined using RECIST criteria, based on radiologic studies conducted every two months. The interim analysis demonstrated a significant improvement in PFS, with a statistically significant 1.7 month difference in median PFS (ridaforolimus, 3.6 months; standard of care, 1.9 months; p≡0.007). Based on these data, further enrollment was stopped and the surviving patients will continue to be followed.