Roche Holdings Ltd. (RHHBY) recently reported positive data from a late-stage trial (EURTAC) on Tarceva (erlotinib). The EURTAC trial was conducted in Western patients with a genetically distinct type of advanced non-small cell lung cancer (NSCLC). The trial results were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.
The study results demonstrated that the first-line use of Tarceva almost doubled the time patients survived without their disease getting worse compared with patients on placebo. The median progression-free survival for patients dosed with Tarceva was 9.7 months versus 5.2 months for patients who were on placebo. Additionally, Tarceva reduced the risk of the disease getting worse by 63% as compared with chemotherapy.
We note that similar results were obtained from another late-stage trail, OPTIMAL, conducted in Asian patients with a genetically distinct type of advanced NSCLC.
Roche currently markets Tarceva as a treatment for advanced lung cancer following platinum-based chemotherapy. Moreover, the company has filed with the European Medicines Agency (EMA) for the extension of Tarceva’s label to include first-line use of the drug in people with advanced EGFR activating mutation-positive NSCLC.
Roche is also in discussions with the US Food and Drug Administration (FDA) to gain approval to use Tarceva as a first-line treatment in people with advanced EGFR activating mutation-positive NSCLC. Moreover, the company is also in talks to gain approval for the use of a companion diagnostic test to help identify patients with activating EGFR mutations, who are appropriate candidates for Tarceva.
While Roche holds the marketing rights to the drug in the US and the European Union, it has a global development and marketing alliance with Astellas Pharma for Tarceva, whereby Astellas and Roche evenly split the sales effort for marketing the drug.
Tarceva primarily faces competition from Eli Lilly & Co.’s (LLY) Alimta, Sanofi-Aventis’ (SNY) Taxotere and AstraZeneca’s (AZN) Iressa.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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