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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

SATURN fails to find predictive biomarker for Tarceva: Roche/OSI's Phase III SATURN trial of Tarceva may help establish erlotinib as first-line maintenance therapy for non-small cell lung cancer patients who did not progress following first-line treatment with platinum-based chemotherapy, but it failed to establish KRAS mutation status as a predictive biomarker for Tarceva. The trial yielded a significant 41 percent improvement in progression-free survival, the primary endpoint, with a stronger PFS impact in patients with EGFR-positive tumors. But pre-planned biomarker analyses found benefit in both KRAS mutant and wild-type patients, though the effect was stronger in patients with KRAS mutations. "The EGFR immunohistochemistry, EGFR FISH and KRAS mutation status were not strong predictive factors, and selection of patients based on these is not warranted," Roche Clinical Science Leader, Tarceva Ivan Melezinak said. Overall survival data is expected to be ready in the second half of 2009. OSI submitted an sNDA to FDA based on the study in March, and Roche has filed for European approval. Results from the similar ATLAS study were also presented (1"The Pink Sheet" DAILY, Feb. 23, 2009); overall survival from that study, which supports the addition of Tarceva to Avastin after platinum chemo/Avastin therapy, are expected toward the end of the year

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