Roche Pharmaceuticals

Roche Announces Collaboration to Investigate New Treatment Strategy With Tarceva in Lung Cancer

Basel, Switzerland (ots/PRNewswire) - - New Phase III Study Will Evaluate if Tarceva is Superior to Traditional Chemotherapy in First Line Treatment of key Group of Patients

Roche and the Spanish Lung Cancer Group (SLCG) today announced their collaboration on the first phase III trial to investigate Tarceva(R) (erlotinib) in lung cancer patients with genetic mutations in their epidermal growth factor receptor (EGFR). Over activity of EGFR is closely 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 has been approved in the EU since September 2005 and in the US since November 2004 for the treatment of 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 tumours 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.

Rafael Rosell from the SLCG 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."

The EURTAC trial is the first prospective, randomised phase III trial to investigate whether first line treatment with Tarceva is superior to chemotherapy in patients with EGFR mutation positive disease. Tarceva has already been shown to significantly extend survival and the time patients with advanced lung cancer live without their cancer getting worse and without the side effects associated with chemotherapy. The results from EURTAC, if positive, will support a submission by Roche to the EMEA to seek an additional new indication for use of Tarceva.

About EGFR

The epidermal growth factor receptor - EGFR - is found on the surface of a cell. When it binds to the cell, it becomes active. It is thought that EGFR is found in clusters on cells. In some people who have changes or mutations in their genes, EGFR can become overactive. When EGFR becomes overactive it can result in uncontrolled cell division, which predisposes an individual to the development of cancer. EGFR is associated with some forms of cancer, including lung cancer. Tarceva (erlotinib) is an EGFR receptor inhibitor, and therefore can block [or dampen] the activity of EGFR. It is because of this mode of action that Tarceva is thought to be effective in treating patients with lung cancer.

About lung cancer

Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006(1). Unfortunately, the majority of cases of non-small cell lung cancer (NSCLC) cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first line treatment option, fewer than 5% of people with advanced NSCLC survive for five years after diagnosis and most die within 12 months(2).

About Tarceva

Tarceva is different from conventional chemotherapies and has been shown to potently inhibit EGFR. It is the first and only EGFR oral targeted agent in second line with a proven and significant survival and symptom benefit in a broad range of patients with advanced lung cancer without the side effects associated with chemotherapy. Tarceva has been approved in the EU since September 2005 and in the US since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Furthermore, Tarceva in combination with chemotherapy is the first treatment in over a decade to have shown a significant survival benefit in treating patients with pancreatic cancer. It is approved in the US in combination with gemcitabine for the first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer and in the EU for treatment of metastatic pancreatic cancer. Since its initial launch three years ago, Tarceva has been used to treat more than 250,000 patients and has been approved in over 80 countries worldwide.

About the Spanish Lung Cancer Group

The Spanish Lung Cancer Group (SLCG) was created in 1991 as an independent non-profit cooperative group whose aim is to promote the study and research of lung cancer. The SLCG is comprised of medical oncology specialists, thoracic surgery specialists, radiotherapy oncology specialists and basic researchers. It encompasses more than 130 centers, both public and private, throughout Spain.

The SLCG has carried out clinical investigation activities in different types of lung cancer and in diverse clinical situations, from initial to advanced stages. In their clinical trials, they have treated more than 8,000 patients. Their results have been reported in more than 300 presentations at international meetings and more than 50 publications in peer-reviewed journals.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information

http://www.roche.com

http://www.thenewsmarket.com (video clips about Tarceva in broadcast standard, free of charge)

References

(1.) Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18: 581-92.

(2.) Boyle P and Bernard L. World Cancer Report 2008. IARC Press, Lyon, pp 309-394, 2008.

Contact:

For further information please contact: George Gauthier at Roche,
Tel:+41(0)61-687-5235; Anna Gray at Galliard, Tel:
+44(0)207-663-2271, Mobile: +44(0)7590-711189

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