the patients had a baseline ECOG performance status (PS) of 1 and 17% had a baseline ECOG PS of 2. Most patients presented with metastatic disease at study entry as the initial manifestation of pancreatic cancer (77% in the TARCEVA arm, 76% in the placebo arm). Survival was evaluated in the intent-to-treat population based on follow-up survival data including 551 deaths. Results are presented for the 100 mg dose cohort (504 deaths) in Figure 4. The adjusted HR for death in the TARCEVA group relative to the placebo group was 0.82 (95% CI: 0.69 0.98;p = 0.028). The percentage of patients alive at 12 months was 23.8% in the TARCEVA group compared to 19.4% in the placebo group. The median overall survival was 6.4 months in the TARCEVA group compared with 6 months in the placebo group. Figure 4: Kaplan-Meier curve for overall survival of patients in TARCEVA 100mg dose cohort by treatment group in Study PA.3 6: Study PA.3 Efficacy Results TARCEVA 100 mg Placebo plus p-value plus gemcitabine gemcitabine (n = 261) (n = 260) Median survival 6.4 months 6 months Hazard ratio, mortality 0.82 0.028 (TARCEVA:placebo) (0.69 0.98) – (95% CI) % patients at 12 months 23.8 19.4 The median PFS was 3.81 months (16.5 weeks) in the TARCEVA group (95% CI; 3.58 4.93) compared with 3.55 months (15.2 weeks) in the placebo group (95% CI; 3.29 3.75; = 0.006). p The median duration of response was 5.5 months, ranging from 0.85 months 12.8+ months. The objective response rate (complete response and partial response) was 8.6% in the TARCEVA group and 7.9% in the placebo group. The proportion of patients who experienced complete response, partial response or stable disease was 59% and 49.4% respectively, for the TARCEVA and placebo groups (p = 0.036). INDICATIONS Non-small cell lung cancer:
the patients had a baseline ECOG performance status (PS) of 1 and 17% had a baseline ECOG PS of 2. Most patients presented with metastatic disease at study entry as the initial manifestation of pancreatic cancer (77% in the TARCEVA arm, 76% in the placebo arm). Survival was evaluated in the intent-to-treat population based on follow-up survival data including 551 deaths. Results are presented for the 100 mg dose cohort (504 deaths) in Figure 4. The adjusted HR for death in the TARCEVA group relative to the placebo group was 0.82 (95% CI: 0.69 0.98;p = 0.028). The percentage of patients alive at 12 months was 23.8% in the TARCEVA group compared to 19.4% in the placebo group. The median overall survival was 6.4 months in the TARCEVA group compared with 6 months in the placebo group. Figure 4: Kaplan-Meier curve for overall survival of patients in TARCEVA 100mg dose cohort by treatment group in Study PA.3 6: Study PA.3 Efficacy Results TARCEVA 100 mg plus gemcitabine (n = 261) Placebo plus gemcitabine (n = 260) p-value Median survival 6.4 months 6 months Hazard ratio, mortality (TARCEVA:placebo) (95% CI) 0.82 (0.69 – 0.98) 0.028 % patients at 12 months 23.8 19.4 The median PFS was 3.81 months (16.5 weeks) in the TARCEVA group (95% CI; 3.58 4.93) compared with 3.55 months (15.2 weeks) in the placebo group (95% CI; 3.29 3.75; p = 0.006). The median duration of response was 5.5 months, ranging from 0.85 months 12.8+ months. The objective response rate (complete response and partial response) was 8.6% in the TARCEVA group and 7.9% in the placebo group. The proportion of patients who experienced complete response, partial response or stable disease was 59% and 49.4% respectively, for the TARCEVA and placebo groups (p = 0.036). INDICATIONS Non-small cell lung cancer:
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