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Atlas is the second positive study that showed Tarceva in the first-line maintenance setting improved progression-free survival (PFS). Another study, Saturn, showed patients who received Tarceva alone as a maintenance treatment following initial chemotherapy had a significant improvement in PFS, compared with placebo.
Avastin is currently approved as first-line treatment in combination with carboplatin and paclitaxel chemotherapy for patients with locally advanced, non-squamous NSCLC. Tarceva is currently approved as a treatment for patients with advanced NSCLC whose disease has progressed after one or more courses of chemotherapy and can be used in patients with either non-squamous or squamous cell NSCLC. Both therapies have been shown to improve overall survival in these indications.
Atlas was a global, multicenter, randomized, double-blind, placebo-controlled study. Patients in the study were treated with Avastin plus four cycles of platinum-based chemotherapy. If the cancer did not progress and patients did not experience significant toxicity, patients (n=743) were then randomized to receive Avastin plus either Tarceva or placebo until progression. PFS, as assessed by investigators, was defined as the length of time from randomization to disease progression or death from any cause.
The 39% improvement in PFS observed in the study can also be referred to as a 28% reduction in the risk of cancer progression or death (hazard ratio=0.72; p=0.0012). Median PFS following four initial cycles of Avastin and chemotherapy was 4.8 months for patients who received the combination and 3.7 months for those who received Avastin plus placebo. Secondary endpoints included safety and overall survival. Overall survival data are expected in the second half of 2009.
Hal Barron, chief medical officer of Genentech, said: "With this study we continue to build on the important advances Avastin has made in the first-line treatment of lung cancer. It is our hope that adding the daily pill Tarceva to Avastin in the maintenance setting may potentially expand the options available for patients with advanced NSCLC who receive Avastin as an initial therapy."
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