Proven survival advantage

Tarceva significantly prolonged overall survival by 37% [1,2]

  • A hazard ratio of 0.73 indicates a 27% reduction in risk of death for patients who received Tarceva. [1]

Slowed disease progression

Tarceva significantly prolonged progression-free survival
by 64% [3]

  • A hazard ratio of 0.61 indicates a 39% reduction in the risk of death or disease progression (P<0.001). [3]

Survival benefit consistent with chemotherapy
  • The pivotal Phase III clinical trial results compare favorably for all efficacy endpoints (response rates, progression-free survival and survival) with the results of chemotherapy in Phase III clinical trials with similar NSCLC patient populations. [4-7]


Results for Tarceva compare favorably with those for similar patient populations treated with chemotherapy
  • In PS 0–1 patients who had received only one prior regimen:
  • median survival was 9.5 months with Tarceva vs 6.7 months with placebo [4,5]
  • median survival was 9.4 months for pemetrexed and 9.1 months for docetaxel [5,6]

Tarceva significantly prolonged progression-free survival and improved disease control in second-line PS 0–1
patients [4]

In the second-line treatment of PS 0–1 patients:
  • Tarceva significantly prolonged progression-free survival (PFS) by 82% vs placebo (HR=0.55; 95% CI=0.41–0.74; P<0.001): [4]
    • Tarceva doubled median PFS vs placebo (3.6 months vs 1.8 months)
  • Tarceva increased the disease control rate (CR+PR+SD) by 63% vs placebo (51.1% vs 31.4%). [4]

Second-line treatment with Tarceva offered PS 0–1 patients a proven survival advantage and an established tolerability profile combined with the ease of oral administration. [1,4]
References: 1. Tarceva® (erlotinib) summary of product characteristics, F. Hoffmann-La Roche Ltd., 2007. 2. Tarceva® (erlotinib) full prescribing information, OSI Pharmaceuticals, Inc., 2005. 3. Shepherd FA, Pereira JR, Ciuleanu T, et al, for the National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005;353:123-132. 4. Data on file, OSI Pharmaceuticals, Inc. 5. Data on file, F. Hoffmann-La Roche Ltd. 6. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004;22:1589-1597. 7. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non–small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000;18:2095-2103.
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