Roche announced that the SATURN (SequentiAl Tarceva in UnResectable NSCLC) study met its primary endpoint of progression free survival. The study showed that Tarceva (erlotinib), when given in first line maintenance - immediately following initial treatment with platinum-based chemotherapy - significantly extended the time patients with advanced non-small cell lung cancer (NSCLC) lived without their cancer getting worse.
Trial investigator, Prof F Cappuzzo, Istituto Clinico Humanitas IRCCS, Milan, Italy, commented, "Lung cancer patients need options to stop the rapid progress of this disease without the side effects of chemotherapy. SATURN shows that Tarceva provides this option and gives new hope to patients and their families."
"Tarceva is already proven to work in patients with advanced lung cancer whose previous treatment has failed," said William M Burns, CEO of the Pharmaceuticals Division at Roche. "This data indicates a role for Tarceva as first-line maintenance treatment for this difficult-to-treat disease to help patients further delay the progression of their cancer."
Lung cancer is the most common cancer worldwide with 1.4 million new cases annually, and NSCLC accounts for almost 80 per cent of all lung cancers. Extending the time patients live without their disease progressing and managing side effects are key treatment goals, so the results of the SATURN study are significant for both physicians and their patients.
The SATURN study results are being fully analyzed and will be presented at a future medical meeting. Roche will discuss with regulatory agencies the data and plans for filing of a new indication for Tarceva.
In a collaboration with OSI Pharmaceuticals and Genentech, Roche will continue an extensive development program of more than 130 clinical studies with Tarceva at earlier stages of the disease and in combination with other treatments including Avastin to further evaluate Tarceva's life-extending benefits for patients with NSCLC lung cancer.
SATURN is a multicenter, double-blind, randomized, prospective phase III study to evaluate the efficacy of Tarceva or placebo in patients with advanced, recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not progressed following first-line platinum-based chemotherapy.
Avastin-based therapy is shown to improve overall survival in previously untreated patients with NSCLC and has the longest overall survival reported in clinical trials in that setting.