Tarceva Shows Improved Survival in Advanced Non-Small Cell Lung Cancer Patients

Strategic Insights -

The New England Journal of Medicine recently published results from a pivotal phase III study demonstrating that Tarceva (erlotinib) improves survival in patients with advanced non-small cell lung cancer (NSCLC). The study, conducted by the U.S. National Cancer Institute of Canada Clinical Trials Group, involved 86 sites from 17 countries and 731 patients with advanced NSCLC who had failed at least one prior chemotherapy regimen. Tarceva, approved by the U.S. Food and Drug Administration (FDA) in November 2004, is the first non-cytotoxic treatment to extend survival in advanced lung cancer.

Key Takeaways:

  • The phase III study showed a 30% reduction in the risk of death (hazard ratio (HR)=0.70) in patients who received Tarceva compared to those who received placebo, with a median survival of 6.7 months and 4.7 months, respectively.
  • The Tarceva-treated patients had a 42.5% improvement in median survival and 31% were alive at 1 year compared to 22% in the placebo arm.
  • Tarceva met all secondary endpoints of the trial, including time to symptom deterioration, progression-free survival, and response rate.
  • The study compared the use of 150mg/day Tarceva vs. placebo in patients with second and third-line relapsed or refractory NSCLC.
  • Tarceva is the first non-cytotoxic targeted therapy shown to extend survival in patients with advanced lung cancer, and further research is necessary to understand which patients will benefit most from the treatment.
  • Tarceva targets the human epidermal growth factor receptor 1 (HER1) pathway, which plays a role in the formation and growth of NSCLC and other solid tumors.
  • The drug has been approved by the FDA, Switzerland, and Canada, and has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending approval.
  • 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.
  • Lung cancer is the single largest cause of cancer deaths in the United States, responsible for nearly 30% of cancer deaths.

Statistics:

  • Median survival: 6.7 months in Tarceva-treated patients and 4.7 months in placebo-treated patients (42.5% improvement).
  • One-year survival rate: 31% in Tarceva-treated patients and 22% in placebo-treated patients.
  • Number of patients: 731 patients with advanced NSCLC who had failed at least one prior chemotherapy regimen.
  • Hazard ratio (HR): 0.70 in favor of Tarceva compared to placebo.
  • Time to symptom deterioration: Tarceva met this secondary endpoint in the trial.
  • Progression-free survival: Tarceva met this secondary endpoint in the trial.
  • Response rate: Tarceva met this secondary endpoint in the trial.

Sources:

  • The New England Journal of Medicine
  • U.S. National Cancer Institute of Canada Clinical Trials Group
  • U.S. Food and Drug Administration (FDA)
  • OSI Pharmaceuticals
  • Genentech, Inc.
  • World Health Organization