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Phase II Clinical Trial/Oral Deforolimus for Advanced NSCLC


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Excerpt from ARTICLE:

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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced the initiation by Merck & Co. Inc., of a Phase 2 clinical trial to evaluate the safety and efficacy of oral deforolimus, ARIAD's investigational mTOR inhibitor, in patients with advanced non-small cell lung cancer. Deforolimus is currently being studied in multiple clinical trials, both alone and in combination with other therapies, in patients with several different types of cancer. Under the terms of the agreement, ARIAD will receive a $10 million milestone payment from Merck upon treatment of the first patient in this clinical study.

The multi-center, randomized, double-blind, placebo controlled clinical trial will compare oral deforolimus against placebo in patients with advanced non-small cell lung cancer whose tumors have a KRAS mutation. The presence of KRAS mutations in lung tumors is a recognized predictor of poor response to EGFR inhibitors such as erlotinib.

The trial utilizes a randomized discontinuation design in which all patients initially receive deforolimus. Those patients who respond to treatment will continue on therapy, while those whose disease is stable will be randomized to continued oral deforolimus or placebo. Supportive care elements for patients are the same in the two arms of the study after randomization. This trial is designed to assess control of disease progression by oral deforolimus. The primary endpoint of the study is progression-free survival in the randomized population.

The clinical trial will enroll approximately 150 patients who have failed two prior treatment regimens. It will be conducted at approximately 38 sites including medical centers in the United States and abroad.

"There is a significant unmet medical need for the treatment of patients with advanced non-small cell lung cancer who have KRAS positive tumors and are refractory to currently available therapies," stated Pierre F. Dodion, M.D., senior vice president and chief medical officer of ARIAD. "The design of this clinical trial is supported by preclinical data on deforolimus that will be presented at the upcoming American Association for Cancer Research meeting this spring and advocates evaluating deforolimus further in this patient population."

This is the fourth Phase 2 clinical trial of oral deforolimus conducted by ARIAD and Merck to begin within the past year.

For more information about clinical trials evaluating deforolimus, or to find a trial site close to you, patients and physicians should call the US toll-free number 1-877-621-2302 or the international number 1-617-621-2302, or email us at ClinicalTrials@ariad.com. Additional information can also be found at www.ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer, both small cell and non-small cell, is the leading cause of cancer death for both men and women. According to the American Cancer Society (ACS), more people die of lung cancer than of colon, breast, and prostate cancers combined. Data from the ACS estimates that about 215,000 new cases of lung cancer were diagnosed in the United States in 2008 and approximately 162,000 people will die from this disease. The vast majority of all lung cancers are the non-small cell type. Prognosis for patients is primarily based on the time of diagnosis relative to the stage of the cancer. There are several treatment options to choose from depending on the stage of the cancer, patient's age and common side effects. Treatment can consist of surgery, radiation, chemotherapy, and new therapies that target the tumor blood vessel growth.

About Deforolimus

ARIAD's lead product candidate, deforolimus, is a novel rapamycin analog that specifically and potently inhibits mTOR, a downstream activator of the PI3K/Akt and nutrient sensing pathways. The mTOR protein acts as a "master switch" in cancer cells. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism, and angiogenesis. Multiple Phase 1 and Phase 2 clinical trials of deforolimus in solid tumors and hematologic cancers have completed, or are in the process of patient enrollment. The global Phase 3 SUCCEED trial of oral deforolimus in metastatic soft-tissue and bone sarcomas is based on a Special Protocol Assessment agreed upon by the U.S. Food and Drug Administration. ARIAD has a global partnership with Merck & Co., Inc. to develop and commercialize deforolimus in patients with cancer.

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(Medical News Today, Lung Cancer; Cancer/Oncology, March 4, 2009. [Contains Forward-Looking Statements])


The information contained in these articles may or may not be in agreement with my own opinions. They are not being posted with the intention of being medical advice of any kind.

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