According to recent results presented at the 3rd International Lung Cancer Congress, the immunotherapy agent GVAX® appears to have anticancer activity in patients with non-small cell lung cancer.

Lung cancer is the leading cause of cancer deaths in the United States and non-small cell lung cancer (NSCLC) is the most common type of lung cancer. There are several types of NSCLC, depending upon which type of cell is affected. Early-stage NSCLC refers to cancer that has not spread to distant sites in the body and treatment may involve surgery, chemotherapy and/or radiation therapy. Although patients with early-stage NSCLC may be able to undergo surgery, some of these patients are at a high risk for their cancer returning. Recurrent NSCLC is cancer that has returned following prior therapy and treatment often involves chemotherapy. Patients with refractory NSCLC currently have a poor prognosis and researchers are evaluating novel therapeutic approaches in order to improve survival and quality of life for these patients.

GVAX® is a novel therapy still being investigated in clinical trials that utilizes a patient’s immune system to fight cancer. The immunotherapy agent is comprised of a patient’s own cancer cells, which are collected and killed with radiation. Researchers then genetically modify the cells so that they secrete granulocyte macrophage colony stimulating factor (GM-CSF), a substance normally produced by the body that stimulates the immune system to attack foreign material, such as viruses, bacteria and cancer cells. The cells are then injected back into the patient and the immune system recognizes cancer cells throughout the body as foreign and attacks them.

Recently, researchers conducted a clinical trial to evaluate the effectiveness of GVAX® in NSCLC. This trial involved 33 patients with either early-stage NSCLC at a high risk for recurrence following surgery or recurrent NSCLC. Patients with recurrent cancer demonstrated an average survival duration of approximately 8 months following treatment with GVAX®. Three patients with recurrent NSCLC achieved a complete disappearance of cancer (remission), with the average remission lasting at least 16 months. Two of these three patients had a type of NSCLC referred to as bronchoalveolar carcinoma (BAC). Seventy percent of patients with early-stage NSCLC who received GVAX® following surgery remained cancer-free at least 16 months following surgery. Treatment was generally well tolerated and no significant side effects attributable to GVAX® were reported.

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These results indicate that GVAX® has minimal side effects and may have anticancer activity in patients with NSCLC. Clinical trials will further evaluate GVAX® in NSCLC and other cancers. Patients with NSCLC may wish to speak with their physician about the risks and benefits of participating in a clinical trial further evaluating GVAX® or other promising therapies. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( cancer.gov) and www.eCancerTrials.com. eCancerTrials.com also provides personalized clinical trial searches on behalf of patients.

Reference: Cell Genesys, Inc. Cell Genesys reports encouraging follow-up data from phase I/II trial of GVAX® lung cancer vaccine; company updates plans for phase III trials of GVAX® vaccines. Availableat:http://www.pharmalive.com/news/show_article_f.asp?articleID=57682&catid=14. Accessed July 2, 2002.

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