In addition to studying ridaforolimus for the treatment of patients with sarcomas, Merck is pursuing a development program in other cancers under its license agreement with ARIAD, both as a single agent and in combination with other targeted investigational therapies.
For specific information on sites and enrollment status on clinical trials with ridaforolimus in various cancers, please visit www.clinicaltrials.gov.
Endometrial cancer
Endometrial cancer, which develops from the inner lining of the uterus, is the most common cancer found in the female reproductive system.
In October of 2010, interim results of a randomized, open-label, active-control multicenter Phase 2 study of oral ridaforolimus were announced in patients with metastatic or recurrent endometrial cancer. Based on this interim analysis, the study demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) in patients receiving single-agent ridaforolimus compared with patients receiving standard-of-care treatment. Full press release here.
Merck is currently evaluating how best to potentially advance ridaforolimus into Phase 3 for endometrial cancer.
Breast cancer
Other than skin cancer, breast cancer is the most common cancer among women in the United States. In this population, it is the second leading cause of cancer death, after lung cancer. Initial treatment consists of surgery alone, or in combination with radiation, chemotherapy, hormonal therapy and/or targeted therapy. Two or more methods are often used in combination. For those women with disease progression, chemotherapy is the only currently available treatment option, and limited benefit has been seen in such cases. We need new therapies.
Merck is currently exploring the use of ridaforolimus in combination with its IGF-1R inhibitor in a Phase 2 study in HER-2 negative, ER-positive, high-proliferation breast cancer.
Combination therapies
Ridaforolimus is being explored in combination with various targeted agents driven by mechanisms of action and biology. Its favorable safety profile makes ridaforolimus an excellent candidate for combination therapy in a number of cancers.
Despite encouraging advances in cancer therapy, prolonged cancer remission remains difficult to achieve in many types of solid tumors. Additional treatment options are needed for patients whose cancer is progressing and unresponsive to currently available therapies. In addition to single-agent ridaforolimus clinical trials, Merck is expected to initiate clinical studies exploring ridaforolimus in combination with currently available treatments to identify more effective treatments for advanced cancers.