In addition to studying deforolimus for the treatment of patients with sarcomas, we anticipate that at least four additional cancer indications will be pursued under our global development plan with Merck; endometrial, prostate, breast and non-small cell lung cancers. We plan to study deforolimus both as a single agent and in combination with various targeted agents driven by mechanisms of action and biology. During 2008, our global development plan calls for initiation of multiple clinical trials, including Phase 2 trials in endometrial, breast and prostate cancers.
For specific information on sites and enrollment status on clinical trials with deforolimus in various cancers, please visit www.clinicaltrials.gov or please email us at TrialDesk@ariad.com.
Endometrial Cancer
Endometrial cancer, which develops from the inner lining of the uterus, is the most common cancer found in the female reproductive system.
The American Cancer Society estimates about 40,100 new cases of endometrial cancer will be diagnosed in the United States and approximately 7,470 women will die from this disease in 2008.* Prognosis for patients is primarily based on the time of diagnosis relative to the stage of the cancer. Initial treatment consists of surgery alone, or in combination with radiation, chemotherapy and/or hormonal therapy. For those women with disease progression, chemotherapy is the only currently available treatment option, and limited benefit has been seen in such cases, emphasizing the need for new therapies.
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.
The American Cancer Society estimates about 182,460 women in the United States will be diagnosed with invasive breast cancer and about 40,480 women will die from the disease in 2008. Currently, it is estimated that there are nearly two and a half million breast cancer survivors in the United States. Improved treatments coupled with early detection are decreasing the risk of dying from breast 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, emphasizing the need for new therapies.
Prostate Cancer
Prostate cancer is the most frequently diagnosed cancer in men, and the second leading cause of cancer death in men.*
The American Cancer Society estimates that approximately 186,320 new cases of prostate cancer will be diagnosed in the United States in 2008 and over 28,660 deaths will occur as a result of this disease.*
The exact cause of prostate cancer is unknown, although certain risk factors such as age, family history, race, diet and exercise have been linked to the disease. Chemotherapy is the standard treatment for patients with hormone-refractory disease; however, its limitations are well documented and all patients eventually become resistant to chemotherapy over time.
Non-Small Cell Lung Cancer
The American Cancer Society estimates approximately 215,020 new cases of lung cancer will be diagnosed in 2008 in the United States, accounting for about 15% of all cancer diagnoses. Lung cancer is classified clinically as non-small cell (13%) or small cell (87%) for the purposes of treatment. Lung cancer accounts for the most cancer related deaths in both men and women. An estimated 161,840 deaths, accounting for about 29% of all cancer deaths, are expected to occur in 2008.*
Treatment options include surgery, radiation therapy, chemotherapy, and targeted biological therapies. Because the disease has usually spread by the time it is discovered, radiation therapy and chemotherapy are often used, sometimes in combination with surgery. Chemotherapy alone or combined with radiation is the typical treatment of choice for small cell lung cancer.
Combination Therapies
Deforolimus is being explored in combination with various targeted agents driven by mechanisms of action and biology. Its favorable safety profile makes deforolimus 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 deforolimus clinical trials, ARIAD and Merck plan to initiate several clinical trials exploring deforolimus in combination with currently available treatments, including HER-2 inhibitors, to identify more effective treatments for advanced cancers.
* Source: American Cancer Society, Cancer Facts & Figures 2008.
