Genentech, OSI Pharmaceuticals report positive Phase III cancer study results

Saturn is a placebo-controlled, randomized, double-blind, Phase III study conducted by Roche that enrolled 889 patients with advanced non-small cell lung cancer (NSCLC) at approximately 160 sites worldwide. Patients were treated with at least four cycles of standard first-line platinum-based chemotherapy and were then randomized to Tarceva or placebo if their cancer did not progress.

The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, safety and an evaluation of exploratory biomarkers.

There were no new or unexpected safety signals in the study and adverse events were consistent with those observed in previous NSCLC clinical trials evaluating Tarceva. OSI, Genentech and Roche will discuss next steps for a potential new indication for Tarceva with the FDA and European Health Authorities.

Tarceva is currently approved as a second-line treatment for patients with advanced NSCLC, who have progressed following treatment with at least one prior chemotherapy regimen, based on a 37% improvement in overall survival compared to placebo.

Gabriel Leung, president of oncology at OSI, said: “We believe that Tarceva as a once-a-day oral therapy, which has a well-established safety profile, may be well-suited as a maintenance therapy in the first-line setting following chemotherapy. We are excited about the prospect that for the first time patients may have a treatment alternative that is different from traditional chemotherapy and extends the time patients live without their cancer progressing following initial treatment.”