Oral ridaforolimus, an investigational mTOR inhibitor, was granted a special protocol assessment (SPA) by the US Food and Drug Administration (FDA) for the SUCCEED trial.
Ridaforolimus improved progression-free survival (PFS) compared to placebo, the primary endpoint of the study.
Secondary endpoints were trends in overall survival (OS), best target lesion response, assessment of cancer-related symptoms, and safety and tolerability.
The independent radiological committee review analysis showed that the proportion of patients alive and free from disease progression in the ridaforolimus group compared to placebo was greater after three months (70% versus 54%), and six months (34% versus 23%).
Based on these results, Merck plans to submit a new drug application (NDA) for ridaforolimus to the FDA and a marketing application in the European Union this year.
As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.