Recent R&D Highlights
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Recent R&D Highlights Tarceva the First Targeted Anticancer Agent to
Prolong SUrvival Tarceva (erlotinib), developed by OSI Pharmaceuticals, Genentech and Roche, is the first epidermal growth factor receptor (EGFR)-targeted anticancer agent to significantly prolong survival in patients with non-small-cell lung cancer (NSCLC), according to a study presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO)." In a phase ill study involving over 700 patients with advanced NSCLC whose disease had progressed despite first- or second-line chemotherapy, overall and progression-free survival durations, time to deterioration of symptoms and response rate were significantly improved in Tarceva, compared with placebo, recipients. TIl
The efficacy of Tarceva was evaluated in a multinational study (BR.21) conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University in Ontario. 1 The study involved 731 patients with advanced NSCLC who received Tarceva 150 mg/ day or placebo. To be eligible for inclusion, patients were required to have stage illB or IV disease and to have experienced treatment failure with first- or second-line chemotherapy (including at least one combination therapy regimen in patients aged < 70 years). Patients were stratified by center, performance status (0 or 1 versus 2 or 3), response to prior chemotherapy (complete or partial response versus stable disease versus progressive disease), the number of prior chemotherapy regimens (one or two), and whether or not they had received prior platinum-based chemotherapy. The baseline characteristics of the treatment groups were similar. The median age of patients was 61 years, and 64% were men. The primary endpoint of the study was the overall survival duration; secondary endpoints included progression-free survival, response rates, and the time to deterioration of key patient-reported lung cancer symptoms (cough, dyspnea and pain). Improved sutvlval and outcomes
A clinically and statistically significant improvement of 42.5% in the median overall survival duration was • The ASCO meeting was held in New Orleans, MS, in June 2004.
Survival and response rates
Tarceva (n=488)
Placebo (n = 243)
Median overall survival duration (months)
6 .7
4.7
Median progression-free survival duration (months)
2.2
1.8
One-year survival rate
31
22
8 .9
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