Swiss drugmaker Roche Holding AG said Tuesday interim results from a phase III study, ATLAS, in patients with advanced non small cell lung cancer shows a combination of Avastin and Tarceva significantly improves the time patients with advanced lung cancer can live without their disease worsening.

The study was stopped early because of the significance of the interim data. The results showed that Tarceva (erlotinib) plus Avastin (bevacizumab) given as first line maintenance treatment following initial therapy with Avastin plus chemotherapy extends the time patients live without their disease getting worse (progression free survival) compared to maintenance therapy with Avastin plus placebo. The results will be welcome news for patients and their physicians as extending the time patients live without their disease advancing is a key treatment aim in lung cancer. Most people with lung cancer are diagnosed with advanced stage disease and die within 12 months of diagnosis1.

"ATLAS is the second study to show that people with lung cancer who took the daily pill Tarceva following initial treatment lived longer without their cancer getting worse" said William M. Burns, CEO Division Roche Pharmaceuticals. " The results build on the strong data currently available for Avastin in first line treatment and Tarceva in second line therapy, and offer a new option to help extend the time these patients live without their disease progressing." A preliminary safety analysis showed adverse events were consistent with previous Avastin or Tarceva studies, as well as trials evaluating the two medicines together, and no new safety signals were observed.

Avastin and Tarceva are already available for the treatment of patients with advanced lung cancer in the US and Europe. Avastin used first line is proven to deliver the longest survival times for patients while Tarceva has a proven record as second and third line treatment for advanced lung cancer. In addition, the SATURN study showed that Tarceva when given in first line maintenance - immediately following initial treatment with platinum based chemotherapy - significantly extended the time patients with NSCLC lived without their cancer getting worse compared to placebo.

Data from the ATLAS study will be submitted for presentation to a forthcoming medical meeting. Roche plans to discuss these data with the regulatory authorities to determine next steps.

About ATLAS (AVF3671g) ATLAS is a global, multicentre, randomised, double blind, placebo controlled study that enrolled 1,157 patients with locally advanced, recurrent or metastatic NSCLC. Patients were initially given first line treatment of four cycles of Avastin in combination with investigators' choice of multiple chemotherapy regimens (carboplatin/gemcitabine, carboplatin/paclitaxel, carboplatin/docetaxel, cisplatin/vinorelbine, cisplatin/docetaxel or cisplatin/gemcitabine). If their cancer did not progress and they did not experience significant toxicity, patients were then randomised (n=768) to receive maintenance therapy with Avastin plus Tarceva or Avastin plus placebo until disease progression. The study's primary efficacy endpoint was postchemotherapy PFS, defined as the length of time from randomisation to either disease progression or death on study treatment. Secondary endpoints included overall survival, incidence of all and serious adverse events, and incidence of treatment discontinuation.

Company Web Site: http://www.roche.com

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