ARTICLE | Clinical News

Ariad proposes follow-on as ridaforolimus meets endpoint

October 26, 2010 12:38 AM UTC

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) proposed a follow-on late Monday after reporting in the morning that oral ridaforolimus met the primary endpoint of significantly improving median progression-free survival vs. standard of care in a Phase II trial to treat advanced endometrial cancer (3.6 vs. 1.9 months, p=0.007). Based on the results, partner Merck & Co. Inc. (NYSE:MRK) stopped further enrollment in the trial, but will continue to collect data from surviving patients. Ridaforolimus also improved median overall survival vs. standard of care (9.3 vs. 8.9 months, p=0.358), but the partners said the trial was not powered to determine statistical significance on this endpoint. Ridaforolimus also led to significantly more serious adverse events vs. standard of care (23.6 vs. 3.8%).

The open-label, international trial enrolled 114 patients with metastatic or recurrent endometrial cancer. Standard of care consisted of oral progestin or chemotherapy. Ridaforolimus is a small molecule inhibitor of mammalian target of rapamycin ( mTOR; FRAP; RAFT1). Data were presented at the International Gynecologic Cancer Society meeting in Prague. The Phase III SUCCEED trial of ridaforolimus to treat metastatic and unresectable soft tissue and bone sarcomas is ongoing. ...