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Study will identify lung cancer patients for upfront Iressa treatment
Using marker of sensitivity, researchers seek to determine response to targeted therapy drug

BOSTON - November 15, 2004 - Earlier this year researchers at two Boston hospitals announced their discovery of a genetic marker that could predict which lung cancers would respond to treatment with the targeted-therapy drug Iressa (gefitinib). Now members of the same teams have launched a study using this marker to identify at the outset patients most likely to respond to the drug. Led by physicians from the Massachusetts General Hospital (MGH) Cancer Center, the clinical trial is the first to use Iressa as an initial treatment for advanced non-small-cell lung cancer (NSCLC), the most common and deadly form of the disease.

"The previous MGH study looked back at a few selected patients in an effort to correlate their response to Iressa with mutations in the drug's protein target," says Lecia Sequist, MD, of the MGH Cancer Center, who will lead the clinical trial under the direction of Thomas Lynch, MD, director of the MGH Thoracic Oncology Center. "Now we will prospectively try to determine the response rate to Iressa in patients known to have these mutations, further testing the principles discovered in the earlier investigations."

In April research teams from the MGH and from Dana-Farber Cancer Institute simultaneously announced discovering that specific mutations in the epidermal growth factor (EGFR) protein identified a subset of NSCLC that was sensitive to treatment with Iressa. One of several new drugs that target the molecular activity underlying cancer development, Iressa disrupts EGFR function, halting a sequence of signals that can lead to malignant tumor growth. Despite the fact that early clinical trials found a significant response in only a few patients, Iressa was approved by the FDA in 2003 because there were no other treatment options for NSCLC patients for whom standard chemotherapy had failed.

The earlier MGH study, published in the New England Journal of Medicine, also found that the identified EGFR mutations accelerated the protein's activity, both stimulating the growth of tumor cells and making the receptors 10 times more sensitive to Iressa's action. In the months following the marker's discovery, a test to screen for the sensitizing mutations was developed by the Laboratory of Molecular Medicine at the Harvard-Partners Center for Genetics and Genomics (HPCGG). The test is currently available to cancer specialists through the HPCGG and will soon be licensed to a commercial diagnostic laboratory for broader availability.

Conducted by a collaborative group organized through the MGH, the new study will enroll patients recently diagnosed with advanced NSCLC who have not yet received any treatment. Potential participants will be tested for EGFR mutations, and those found to have the sensitizing mutations will receive Iressa as a first-line treatment, instead of after the failure of other therapies as is current practice. Patients without the sensitizing mutations may be referred to other, more appropriate clinical trials.

The researchers anticipate screening 150 NSCLC patients in order to identify 30 mutation-positive participants. The trial, which is anticipated to run for one to two years, is being sponsored by AstraZeneca, the manufacturer of Iressa. Additional information is available by calling the MGH Cancer Center at (877) 726-5130 and asking for information about the TARGET trial.

"We all know that cancer is different in different people and that no one treatment will work for everyone," says Lynch, who is principal investigator of the new study. "As one of the first attempts to 'personalize' cancer therapy, this trial will be a great step forward in matching treatments with the patients most likely to benefit from them."

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School (HMS). The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $400 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, MGH and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and nonacute and home health services.

In 2001, HMS and Partners created the Center for Genetics and Genomics with the mission to promote genetics and genomics in research and clinical medicine at Partners and HMS-affiliated institutions.

Media Contacts: Sue McGreevey, MGH Public Affairs

Lee Chelminiak, Harvard-Partners Center for Genetics and Genomics

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