Roche is looking to expand use of its oncology agent Tarceva to treat lung cancer patients who have a certain form of gene mutation, the same one that AstraZeneca’s Iressa has just received a positive recommendation for in Europe.

Specifically, Roche and the Spanish Lung Cancer Group are to collaborate on a Phase III trial to investigate Tarceva (erlotinib) in lung cancer patients with genetic mutations in their epidermal growth factor receptor (EGFR), the overactivity of which is associated with the development of lung cancer. The EURTAC study will evaluate whether Tarceva is a superior option for initial treatment of patients with EGFR mutation positive disease than chemotherapy.

Roche noted that Tarceva has already been shown to significantly extend survival and the time patients with advanced lung cancer live without their disease getting worse and without the side effects associated with chemotherapy. It has also been demonstrated that all patients who do not have the mutations benefit from the drug which has been approved in Europe since September 2005 and in the USA for patients with metastatic non-small cell lung cancer after failure of at least one chemotherapy.

The SLCG’s Rafael Rosell said that "clinical evidence has already shown a dramatic response to Tarceva among lung cancer patients with mutations on the EGFR gene”. Results from small studies to date suggest that patients with these genetic mutations may benefit from earlier treatment with Tarceva, “which could lead to significant survival benefits”, he added.

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 patients in the West. The results from EURTAC, if positive, will support a submission by Roche to the European Medicines Agency to seek an additional new indication for use of Tarceva.

Roche unveiled its plans a day after the EMEA’s Committee for Medicinal Products for Human Use issued a positive opinion on AstraZeneca’s Iressa (gefitinib) for locally advanced NSCLC with activating mutations of EGFR-tyrosine kinase. Deutsche Bank analyst Michael Leuchten believes that a launch of Iressa in Europe will not necessarily pose a threat to Tarceva and the market is big enough for both drugs to prosper. “We don't doubt that Iressa will find its place in the treatment of non-small cell lung cancer, but see little risk to the Tarceva franchise," he said.

Meantime it has been reported that Cipla has prevailed in a court case that will allow the firm to continue selling its generic version of Tarceva in India.

A court in Delhi has dismissed a plea by Roche which had filed an infringement petition after Cipla launched its version of erlotinib, called Erlocip in January last year. Girish Telang, managing director of Roche India Scientific Co, told the Buisness Standard newspaper that “we are yet to get a copy of the order. We will soon decide whether to appeal the decision in the Supreme Court”.