Tarceva Helps Patients With Genetically Distinct Form of Lung Cancer Live Longer

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- Phase II Study Points to Importance of EGFR Biomarker to Identify Patients who can Gain Exceptional Survival BenefitsNew data show that first-line treatment with Tarceva(R)(erlotinib) delivered exceptional survival benefits in patients with advanced lung adenocarcinoma (a form of non small cell lung cancer) with epidermal growth factor receptor (EGFR) activating mutations.[1] The phase II data show that Tarceva plus chemotherapy resulted in median overall survival of 39 months and Tarceva alone gave a median survival of 31.3 months. Patients with advanced lung cancer typically survive for only about 12 months with chemotherapy alone[2]. The data are from CALGB 30406, a study led by the US Cancer and Leukemia Group B and were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago, USA.

Non small cell lung cancer (NSCLC) with EGFR activating mutations is considered to be a genetically distinct form of lung cancer which is most common in patients who have never smoked, patients with adenocarcinoma, people of Asian origin and females.[3],[4]

"The exceptional survival benefits seen when Tarceva is given to patients with advanced lung cancer that has EGFR activating mutations suggest that we may be able to make further progress against this devastating disease," said Dr. Luis Paz-Ares, M.D., Hospital Universitario Virgen del Roc?o, Seville, Spain and lead author of a recent pooled analysis of clinical outcomes in patients with NSCLC with EGFR activating mutations.[3]

Two prospective phase III studies of Tarceva in NSCLC with EGFR activating mutations are ongoing. The EURTAC trial involves patients in Spain, Italy and France and the OPTIMAL trial involves patients in China.

About CALGB 30406

- CALGB 30406 was a randomised, prospective phase II trial designed to evaluate Tarceva alone or in combination with chemotherapy (carboplatin and paclitaxel) and the impact of EGFR activating mutations on outcomes in never or light former smokers diagnosed with advanced lung adenocarcinoma (a form of NSCLC). The study involved 181 patients and the primary endpoint was progression free survival (PFS).

- Overall people who received Tarceva plus chemotherapy lived a median of 19.6 months and those who received Tarceva alone lived a median of 24.3 months (median PFS 6.6 months and 6.7 months, respectively).

- The group of people whose tumours had EGFR activating mutations who received Tarceva plus chemotherapy lived a median of 39.0 months. Those who received Tarceva alone lived a median of 31.3 months.

- The group of people whose tumours did not have EGFR activating mutations who received Tarceva plus chemotherapy alone lived a median of 13.7 months. Those who received Tarceva alone lived a median of

18.1 months.

- Fewer severe (grade 3 or 4) adverse events were observed with Tarceva alone compared to Tarceva plus chemotherapy.

CALGB 30406 data presentation: 15:00 CDT Monday 7 June, Lung Cancer - Metastatic Oral Abstract Session, E Hall D2: Randomized Phase II trial of erlotinib (E) alone or in combination with carboplatin/paclitaxel (CP) in never or light former smokers with advanced lung adenocarcinoma; P.A. J?nne, et al. J Clin Oncol 28:7s, 2010 (suppl; abstr 7503).

About EGFR in lung cancer

EGFR is a protein which sits across the cell membrane to which epidermal growth factor (EGF) binds.[5] When binding happens it activates an enzyme called tyrosine kinase which triggers a complex signalling cascade that leads to events including accelerated cell growth and division, development of metastasis and angiogenesis.[6],[7] Some NSCLC tumours possess activating mutations in the EGFR gene, changing the structure of the EGFR proteins that they code for such that they have increased activity.

About Tarceva

Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit (epidermal growth factor) EGFR, a protein involved in the growth and development of cancers. Tarceva is the first and only EGFR inhibitor to be approved for use in maintenance and second-line treatment settings in patients with advanced or metastatic NSCLC. It is also the only EGFR inhibitor to have shown activity in patients irrespective of EGFR activating mutation status. In both maintenance and second-line settings, Tarceva has a proven and significant survival and symptom benefit without the side effects associated with chemotherapy. In addition, 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. Since initial launch Tarceva has been used to treat more than 400,000

About Roche

Information about the Roche Group is available on the Internet at http://www.roche.com .

References

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[1] Randomized Phase II trial of erlotinib (E) alone or in combination

[2] Earle, CC. Chest 2000; 117: 1239-46.

[3] Paz-Ares, et al; J. Cell. Mol. Med, 2010.

[4] Mitsudomi T, Yatabe Y. Cancer Sci 2007;98:1817-24.

[5] http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_051308/page3 .

Accessed 25.03.10

[6] Prenzel N et al. Endocrine-Related Cancer. (2001). 8:11-31.

[7] Britten CD. Mol Cancer Ther; 2004. 3 1335-42.

SOURCE: Roche Tarceva

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