Survival Results

Proven survival benefit in unselected patients with advanced NSCLC

• Tarceva (erlotinib) significantly improved overall survival, the primary endpoint, by 37% in patients with relapsed Stage IIIB/IV NSCLC vs placebo (P<0.001).^{1, 2}
  • median survival lengthened by 42.5% vs placebo (6.7 months vs 4.7 months)
• In the single-agent NSCLC Phase III trial, the hazard ratio (based on a log-rank test) was used prospectively to define the primary endpoint of overall survival. A hazard ratio <1.0 indicates Tarceva had a survival benefit.¹
• Hazard ratio of 0.73 indicates a 27% reduction in risk of death for patients who received Tarceva.^{1, 2}

Tarceva increased 1-year survival

• One-year survival with Tarceva was 31.2% vs 21.5% with placebo.¹

Impact on time to progression and disease control rate

• Tarceva significantly prolonged progression-free survival by 69% in patients with relapsed Stage IIIB/IV NSCLC-hazard ratio of 0.59 indicates that the risk of death or disease progression was reduced by 41% (P<0.001).¹

Disease control rate improved with Tarceva

• In the pivotal trial, BR.21, the disease control rate (CR+PR+SD) for patients receiving Tarceva was 44.0% vs 27.5% for placebo.^{1, 2}
• The median duration of disease control was 6.0 months (95% CI=5.7-7.4; n=188) with Tarceva vs 4.7 months (95% Cl=3.7-5.5; n=58) for placebo (HR=0.53; P=0.0002).^{1, 2}

Tarceva increased tumor response rate and lengthened median duration of response

• Tarceva significantly increased tumor response rate vs placebo (8.9% vs 0.9%, P<0.001).¹
• In patients with a response to Tarceva, the median duration of response (CR+PR) was 7.9 months (n=38).¹

Survival benefit in second-line, PS 0-1 patients

A retrospective analysis of patients by ECOG Performance Status (PS) and line of therapy.

• In a retrospective analysis of PS 0-1 patients receiving second-line Tarceva:²
  • median survival was lengthened by 40% vs placebo (9.4 months vs 6.7 months)
  • one-year survival rate was increased by 33% vs placebo (40% vs 30%)
  • progression-free survival was significantly prolonged by 79% vs placebo (HR=0.56; 95% CI=0.42-0.75; P<0.001)

*Stratification factor as documented at baseline; distribution differs slightly from values reported at time of randomization.

NSCLC efficacy overview

• Tarceva significantly prolonged overall survival by 37% (P<0.001).¹
  • one-year survival rate increased by 45% vs placebo (31.2% vs 21.5%)¹
  • median survival lengthened by 42.5% vs placebo (6.7 months vs 4.7 months)^{1, 2}
• Tarceva significantly prolonged progression-free survival by 69% - a hazard ratio of 0.59 indicates that the risk of death or disease progression was reduced by 41% (P<0.001).¹
• In a retrospective analysis, Tarceva significantly prolonged overall survival for second-line, Performance Status (PS) 0-1 patients by 47% (HR=0.68; P=0.018) and lengthened median survival by 9.4 months vs 6.7 months for placebo.²
• Although the survival benefit extended to a diverse patient population, in a retrospective, exploratory subset analysis, Tarceva appeared to offer a greater relative survival benefit for EGFR positive (HR=0.68) and nonsmoking patients (HR=0.42)¹

Survival benefit across diverse patient groups

Tarceva demonstrated a significant 37% improvement in overall survival in a large, randomized, placebo-controlled trial of unselected patients with advanced NSCLC.¹

• In exploratory univariate analyses, the effect on survival was shown to be similar in most patient populations.¹
• Some factors were associated with a greater response, but there are no known patient populations that would exclude a positive treatment effect.¹

• Please see full prescribing information

• 1. Tarceva® (erlotinib) full prescribing information,OSI Pharmaceuticals,Inc., 2009.
• 2. Data on file, OSI Pharmaceuticals, Inc.