Ridaforolimus demonstrates activity in advanced endometrial cancer but is associated with significant toxicity, according to a recent study published online ahead of print in the Journal of Clinical Oncology.

Amit Oza, FRCP, of the Princess Margaret Cancer Centre in Toronto, and fellow researchers observed 133 women with metastatic or recurrent endometrial cancer who were randomized to either oral ridaforolimus or a comparator (progestin or investigator choice chemotherapy).

Primary endpoint was progression-free survival that was measured by independent radiologic review.

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Treatment was discontinued as a result of disease progression in 38 percent of patients on ridaforolimus compared to 71 percent on comparator.

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Median progression-free survival at interim analysis was 3.6 months for the ridaforolimus group compared to 1.9 months with comparator. Progression-free survival rate for ridaforolimus was 48 percent compared to 18 percent with comparator at 16 weeks, as well as 39 percent and 15 percent, respectively, at 24 weeks.

Additionally, treatment was discontinued due to adverse events in 33 percent of patients who were on ridaforolimus compared to 6 percent on comparator. Common grade 3 toxicities were hyperglycemia, anemia and diarrhea.


  1. Oza, Amit M., et al. “Randomized Phase II Trial of Ridaforolimus in Advanced Endometrial Carcinoma.” Journal of Clinical Oncology. doi: 10.1200/JCO.2014.58.8871. [epub ahead of print]. June 15, 2015.