Endometrial Cancer

February 17, 2014

Aeterna Zentaris reported results of a phase II trial of zoptarelin doxorubicin (AEZS-108) for the treatment of endometrial cancer. Forty-four patients entered into the study at eight centers in Germany and three centers in Bulgaria. Forty-three of these patients were eligible. Two patients had a complete remission (5%) and eight achieved a partial remission (18%). Stable disease for at least six weeks was observed in 44%. The median time to progression (TTP) was seven months and median overall survival (OS) was 15 months. The most frequently reported grade 3 or 4 adverse effects were neutropenia (12%) and leucopenia (9%). Data showed zoptarelin doxorubicin has clinically meaningful activity with low toxicity in women with advanced or recurrent LHRH receptor positive endometrial cancer, supporting the principle of receptor mediated targeted chemotherapy. These results were the basis of a phase III trial of zoptarelin doxorubicin, currently enrolling.

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.