NEW YORK, October 22, 2003-- A new anti-cancer agent designed to block the signals responsible for telling cancer cells to grow has shown promising results for patients with advanced non-small cell lung cancer. The results of a double blind, randomized trial of the compound, gefinitib (Iressa), led by Dr. Mark Kris, chief of thoracic oncology at Memorial Sloan-Kettering Cancer Center, are published in the October 22 Journal of the American Medical Association. A subset of the data from this clinical trial formed the basis for approval of the drug by the Food and Drug Administration on May 5, 2003.

"This compound is the first new way to treat lung cancer in decades, and this is good news," said Dr. Kris, lead investigator of the multi-center trial. "It is what all people trying to fight cancer want; a pill that specifically attacks the cancer yet does little to adversely effect the person."

Gefinitib is a "designer" drug that targets and blocks an enzyme called tyrosine kinase, part of the epidermal growth factor receptor. Found on the cell surface, the epidermal growth factor receptor is over-expressed in many non-small cell lung cancers. When the epidermal growth factor response is activated, it signals tumor cells to proliferate and grow. When the signal is disrupted, the tumors regress and apoptosis or cell death occurs.

A double-blind, randomized phase II clinical trial of gefinitib was conducted at thirty academic and community oncology centers in the United States. Participating were 221 patients who had either stage IIIB or IV non-small cell lung cancer for which they had received at least two prior chemotherapy regimens. The drug, taken in pill form, was taken daily in doses of either 500 mg (administered as two 250 mg gefinitib tablets) or 250 mg (administered as one 250 mg gefinitib tablet and a matching placebo). Of the 221 patients enrolled, 216 received the randomized doses. '"/>

Contact: Joanne Nicholas
mediastaff@mskcc.org
212-639-3573
Memorial Sloan-Kettering Cancer Center
21-Oct-2003

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