Roche, SLCG To Investigate new Tarceva Strategy

Roche and the Spanish Lung Cancer Group (SLCG) will collaborate on the first Phase III trial to investigate Tarceva in lung cancer patients with genetic mutations in their epidermal growth factor receptor (EGFR). Over activity of EGFR is associated with the growth and development of lung cancer.

It has been demonstrated that all patients who do not have the mutations (called ‘wild type’) benefit from Tarceva, which is approved for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Previous results from smaller trials suggest that tumors with mutations are highly sensitive to treatment with Tarceva. As many as one in three Asian patients with lung cancer have EGFR genetic mutations and they are estimated to be present in 10% of lung cancer patients in the Western population.

The Phase III EURTAC trial will investigate whether first line treatment with Tarceva is superior to chemotherapy in patients with EGFR mutation positive disease. The results from EURTAC, if positive, will support Roche’s submission to the EMEA seeking a new indication for Tarceva.

SLCG’s Rafael Rosell commented, “Clinical evidence has already shown a dramatic response to Tarceva among lung cancer patients with mutations on the EGFR gene. The identification of EGFR mutations represents a novel prognostic and predictive strategy in the treatment of lung cancer. This means that patients with these genetic mutations may benefit from earlier treatment with Tarceva, which could lead to significant survival benefits. The Phase III EURTAC trial will evaluate whether Tarceva is a superior option for initial treatment of lung cancer patients with EGFR mutation positive disease than chemotherapy.”