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Roche Reports Positive Data From Final Analysis of Phase III Lung Cancer Study

September 16, 2008

Roche has announced that the final analysis of the Avastin in lung study in patients with advanced lung cancer has shown that not only did the drug significantly slow down the disease progression, it also enabled some patients to survive for over one year, the longest survival ever reported in patients with this advanced disease.

The Phase III Roche-sponsored AVAiL study in patients with previously untreated, advanced non-small cell lung cancer (NSCLC), has confirmed that Avastin (bevacizumab) combined with gemcitabine-cisplatin chemotherapy offers a significant improvement in the time that patients live without their disease progressing over chemotherapy alone.

Furthermore, although the study was not designed to demonstrate an overall survival benefit, it was analyzed as a secondary endpoint. The analysis showed that while the increase in overall survival was not statistically significant, the median overall survival for patients in all arms of the study exceeded 13 months – the longest survival reported in a study of patients with advanced NSCLC.

AVAiL is the second Phase III trial to demonstrate the significant clinical benefits of Avastin in NSCLC. Previously, the E4599 study, conducted in the US, showed that adding Avastin to a different platinum based chemotherapy (carboplatin-paclitaxel) resulted in a significant improvement in overall survival (its primary endpoint) compared to chemotherapy alone.

Christian Manegold, principal investigator of the study, said: “AVAiL confirms for the second time that Avastin provides important clinical benefits and the longest survival reported for patients with advanced nonsquamous NSCLC. These results once again support Avastin based therapy as first-line standard of care in the vast majority of these patients with good clinical condition.”




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