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Phase II Study of Erlotinib in Non-Small Cell Lung Cancer Patients Initiated

MELVILLE, N.Y.--(BUSINESS WIRE)--March 19, 2004--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - News) today announced that it has initiated a Phase II randomized study of monotherapy Tarceva(TM) (erlotinib HCl) versus standard chemotherapy of previously untreated non-small cell lung cancer (NSCLC) patients with a poor performance status. Tarceva(TM), OSI's leading drug candidate, is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor, thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva(TM) is being developed in a global alliance among OSI, Genentech and Roche.

"Advanced NSCLC patients with a designated poor performance status generally have a low tolerance to standard first-line combination chemotherapy," stated Nicole Onetto, MD, Executive Vice President and Chief Medical Officer at OSI Pharmaceuticals. "This study is designed to evaluate monotherapy Tarceva(TM) as a therapeutic option to standard chemotherapy treatment for this high-risk sub-population of NSCLC patients."

This multi-center, open-label, randomized study is scheduled to enroll up to 102 patients. The study is designed to evaluate in parallel the efficacy and safety of Tarceva(TM) monotherapy and of a standard chemotherapy combination (paclitaxel and carboplatin) in poor performance status patients with previously untreated NSCLC. The primary endpoint of this trial is progression-free survival and secondary endpoints include disease-related symptom benefit, tumor response and overall survival. Tarceva(TM) will be administered at 150mg/day.

In this trial a patient's performance status is measured by the Eastern Cooperative Oncology Group (ECOG) Performance Scale. The Scale ranks the global function of cancer patients according to their level of activity and symptoms from PS0 to PS4 with PS0 patients being fully ambulatory and asymtomatic. To be eligible for this trial, patients need to have moderately impaired performance status graded as 2 (PS2). A PS2 rating is defined as capable of self-care but unable to carry out any work activities; up and about more than 50 percent of waking hours.

About Tarceva(TM)
Tarceva(TM) is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is critical to cell growth in many cancers. HER1, also known as EGFR, is a key component of the HER signaling pathway, which often is involved in the formation and growth of numerous cancers. Tarceva(TM) is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which blocks tumor cell growth.

About Non-Small Cell Lung Cancer
According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States and is responsible for nearly 30 percent of cancer deaths in the country. NSCLC is the most common form of lung cancer and accounts for almost 80 percent of all cases. At the time of diagnosis, approximately 40% of patients with inoperable NSCLC present with PS2.

Source: OSI Pharmaceuticals, Inc.

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