Tarceva® During Therapy for Advanced NSCLC Improves Progression-free Survival

Tarceva® During Initial Therapy for Advanced NSCLC Improves Progression-free Survival

Tarceva® (erlotinib) used immediately following initial chemotherapy for advanced non®small cell lung cancer significantly improved progression-free survival. These results were recently released in a joint press release by Genentech, Inc. and OSI Pharmaceuticals, Inc.

Lung cancer remains the leading cause of cancer deaths in the United States. Non®small cell lung cancer (NSCLC) accounts for approximately 75-80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from the lung to other sites in the body. Because long-term survival for patients with advanced NSCLC remains suboptimal, treatment is aimed at extending the duration of survival for patients while maintaining an optimal quality of life.

Tarceva is a targeted agent that may be used for treatment of patients with NSCLC that has stopped responding to prior therapies. It works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication and when mutated or altered, excessive replication of cells can occur. Tarceva reduces the uncontrolled replication and growth of cancer cells by blocking mutated EGFR pathways.

Research has indicated that patients with specific mutations and/or disease characteristics may respond better to Tarceva than patients without these mutations and characteristics. Research continues in an attempt to specifically determine which patients may derive the greatest benefit from treatment with Tarceva. Furthermore, Tarceva is not associated with the side effects of chemotherapy and/or radiation therapy, giving some patients who are not eligible for standard therapies due to side effects an effective treatment alternative. Tarceva is currently approved for treatment of NSCLC that has stopped responding to prior therapies.

Researchers from several countries recently conducted a Phase III (phase prior to FDA review) trial, referred to as the SATURN trial, evaluating Tarceva as part of an initial treatment regimen for patients with advanced NSCLC. The trial included nearly 900 patients who were treated with initial chemotherapy followed immediately by Tarceva or placebo. Overall, progression-free survival was significantly improved among patients who received Tarceva compared with those who received placebo.

Data from the trial will be released at an upcoming medical meeting.

Reference: Genentech. Phase III Study (SATURN) Showed Tarceva Improved Progression-Free Survival as a First-Line Maintenance Therapy for Advanced Non-Small Cell Lung Cancer. Available at: http://www.gene.com/gene/news/press-releases/display.do®method=detail&id=11647. Accessed November 7, 2008.

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