This is the first time an EGFR-TKI, such as IRESSA, has proven non-inferiority for overall survival relative to chemotherapy in a head-to-head phase III study in patients with pre-treated advanced NSCLC.
The INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study recruited 1466 patients and compared overall survival between IRESSA and docetaxel, in the largest phase III study ever reported comparing two active treatments for pre-treated advanced NSCLC.
Dr Edward Kim Assistant Professor of Medicine, MD Anderson Cancer Center, Houston, Texas, and Co-Principal Investigator for the INTEREST study said: "This large study validates the role of targeted therapy when compared to chemotherapy in previously treated advanced NSCLC patients. The study showed that IRESSA was as effective as docetaxel but with a more favourable tolerability profile, resulting in significantly more IRESSA-treated patients experiencing clinically important improvements in quality of life compared with patients who received docetaxel. Clearly, improving efficacy while minimizing toxicity is the direction advanced cancer therapy is going."
AstraZeneca is sharing these data with regulatory agencies.
IRESSA is currently approved for the treatment of advanced NSCLC in 36 countries. Worldwide sales of IRESSA for the first six months of 2007 reached $113 million.
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