Ridaforolimus: Interim Phase II data

Interim data from an open-label, international Phase II trial in 114 patients with metastatic or recurrent endometrial cancer showed that oral ridaforolimus met the primary endpoint of significantly improving median PFS vs. standard of care (SOC; oral progestin or chemotherapy) (3.6 vs. 1.9 months, p=0.007). Based on the results, Merck said it stopped further enrollment in the trial, but will continue to collect data from surviving patients. Ridaforolimus produced 17 cases of stable disease compared to 2 objective responses and 8 cases of stable disease for SOC. Additionally, ridaforolimus improved median OS vs. SOC (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. SOC (23.6 vs. 3.8%). Data were presented at the International Gynecologic Cancer Society meeting in Prague. ...