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]
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]
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]
Slowed disease progression
Tarceva significantly prolonged progression-free survival by 64%. [3]
A hazard ratio of 0.61 indicates a 39% reduction in risk of progression of disease for patients who received Tarceva.[3]
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]
References:
- Tarceva® (erlotinib) summary of product characteristics, F. Hoffmann-La Roche Ltd., 2007.
- Tarceva® (erlotinib) full prescribing information, OSI Pharmaceuticals, Inc., 2005.
- 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.
- Data on file, OSI Pharmaceuticals, Inc.
- Data on file, F. Hoffmann-La Roche Ltd.
- 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.
- 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.
Tarceva.com
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