Healthcare Industry News:  Herceptin 

Biopharmaceuticals Oncology

 News Release - December 13, 2006

Lapatinib (Tykerb(R)) to be Evaluated in Early Stage Disease in Adjuvant Breast Cancer Settings Internationally

First Global Trial Investigates Lapatinib in Adjuvant Settings to Assess Impact in Early Stage Disease

PHILADELPHIA and BOSTON, Dec. 13 (HSMN NewsFeed) -- GlaxoSmithKline and Massachusetts General Hospital Cancer Center today announced the initiation of a landmark international breast cancer clinical trial, TEACH (Tykerb® Evaluation After CHemotherapy). This will be the first Phase III study to investigate whether adjuvant treatment with lapatinib (Tykerb®) will improve disease-free survival in women with early-stage HER2 (ErbB2)-positive breast cancer, including those with positive and negative node involvement. An adjuvant therapy is one that is administered in addition to primary surgical or radiation treatment to lower risk of disease progression. Approximately 3,000 women will be enrolled from more than 450 centers in more than 30 countries. Lapatinib is an investigational drug that is not marketed for any indication in any country at this time.

"The initiation of this trial represents another step toward understanding the role of targeted therapies in extending disease-free survival," said Dr. Paul Goss, Director of Breast Cancer Research, Massachusetts General Hospital Cancer Center, who proposed the TEACH study and will chair the International Steering Committee. "Women who have HER2-positive breast cancer are at a high risk of the disease returning, which is of great concern to patients and physicians. The landmark TEACH study will be the first to investigate the use of a dual EGFR and HER2 inhibitor as an adjuvant treatment for women with HER2-positive breast cancer."

Between 20% and 30% of human breast cancers overexpress HER2(1,2). Because of the distinct clinical features of HER2-positive breast cancer, women have a high risk of disease recurrence and thus, poorer prognosis(3). In current clinical practice trastuzumab (Herceptin®) is now becoming part of standard adjuvant therapy together with chemotherapy. However, many thousands of women with HER2-positive cancer have already received adjuvant therapy without trastuzumab. Although these patients remain at elevated risk of relapse, there is no data to support initiating additional trastuzumab treatment in patients who did not receive trastuzumab within seven weeks of completing their adjuvant therapy. In addition, trastuzumab is not licensed for use in all countries.

"Researchers are continually seeking ways to stay one step ahead of cancer. We must be proactive with treatments for women who have a distinctive disease prognosis -- those with HER2-positive breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GlaxoSmithKline is excited that lapatinib will be used in the first study that will investigate the use of a dual EGFR and HER2 inhibitor as an adjuvant treatment for these women -- the TEACH trial."

Lapatinib is a dual kinase inhibitor that potently blocks the action of both EGFR (ErbB1) and HER2 receptors within the cancer cell, which are associated with cell proliferation and tumor growth(4). A small molecule tyrosine kinase inhibitor once-daily oral medication, lapatinib is currently in late-stage clinical development for the treatment of patients with advanced metastatic breast cancer and in earlier phases of investigation for treatment of a range of other solid tumors. In a phase III study of Tykerb in combination with capecitabine in patients who have progressed on Herceptin treatment was stopped early by an Independent Data Monitoring Committee due to positive results. The registration approval is currently under review by regulatory authorities in US and various EU/International countries.

About TEACH

The TEACH trial will be conducted at approximately 450 clinical research sites globally and approximately 3,000 women will be enrolled. The study is designed to compare the efficacy and safety of lapatinib versus placebo in women treated for early-stage, HER2-positive breast cancer who have no clinical or radiographic evidence of disease. Participants must have completed primary adjuvant chemotherapy prior to study entry but must not have received trastuzumab. Patients will be randomized to receive lapatinib 1500mg or matching placebo orally administered once daily. Women will continue treatment for a maximum of 12 months or until disease recurrence, development of a second primary cancer, withdrawal from study drug due to unacceptable toxicity, or consent withdrawal. All women will be followed until death or until study closure. The primary efficacy endpoint for analysis is disease- free survival. For further information doctors can visit http://www.clinicaltrials.gov or call 1-877-379-3718.

TEACH Steering Committee

The TEACH trial was proposed by the study chair Dr. Paul Goss, Director of Breast Cancer Research, Massachusetts General Hospital Cancer Center. The study protocol was established through the collaboration of members on the TEACH Steering Committee, which includes the following panel of leading world experts: Dr. Frances Boyle, Sydney, Australia; Dr. Aman Buzdar, Houston, Texas, USA; Dr. Bent Ejlertsen, Copenhagen, Denmark; Dr. Dianne Finkelstein, Boston, Massachusetts, USA; Dr. Pierre Fumoleau, Dijon, France; Dr. William Gradishar, Chicago, Illinois, USA; Dr. James Ingle, Rochester, Minnesota, USA; Dr. Manfred Kaufmann, Frankfurt, Germany; Dr. Julie D. Maltzman, Collegeville, Pennsylvania, USA; Dr. Miguel Martin, Madrid, Spain; Dr. Beverly Moy, Boston, Massachusetts, USA; Dr. Joyce O'Shaughnessy, Dallas, Texas, USA; Dr. Martine Piccart, Brussels, Belgium; Dr. Kathleen Pritchard, Toronto, Canada and Prof Ian Smith, London, UK.

About Massachusetts General Hospital Cancer Center

An integral part of one of the world's most distinguished medical centers, the Massachusetts General Hospital Cancer Center is chosen by more cancer patients than any other hospital in New England. Its commitment to eradicating cancer is fueled by scientific investigation conducted as part of the largest hospital-based research program in the United States. Known for providing individualized, compassionate care to both adults and children, the Cancer Center is comprised of 16 fully integrated, multidisciplinary clinical programs and a vast network of support and educational services. The Cancer Center is consistently ranked as one of the best in the country by U.S. News and World Report, and Massachusetts General Hospital nurses were the first in the state to achieve Magnet status as part of a hospital-wide recognition for exceptional nursing care.

Through a powerful synergy between scientists in the laboratories and physicians at the bedside, the Cancer Center fosters innovation in basic, translational and clinical research. It is a founding member of the DF/HCC, a Harvard Medical School consortium designated by the National Cancer Institute as a comprehensive cancer center. This prestigious seven-member center comprises the largest research collaboration in the country. Also, through the DF/PCC partnership, the Cancer Center and Dana-Farber/Brigham & Women's Cancer Center collaborate on joint clinical trials, education, training programs and quality of care improvements.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.

Notes to editors

Lapatinib was discovered by GlaxoSmithKline and is being developed as an orally administered therapy for breast cancer and other solid tumors. Tykerb® (lapatinib) is a registered trademark of the GlaxoSmithKline group of companies in the United States and Europe.

Herceptin® is a registered trademark of Genentech, Inc. in the U.S. and Roche Pharmaceuticals in Europe.

References

(1) Yeon CH, Pegram MD. Anti-erbB-2 antibody trastuzumab in the treatment of HER2-amplified breast cancer. Invest New Drugs. 2005 Oct;23(5):391- 409.

(2) Brand FX, Ravanel N, Gauchez AS, Pasquier D, Payan R, Fagret D, Mousseau M. Prospect for anti-her2 receptor therapy in breast cancer. Anticancer Res. 2006 Jan-Feb;26(1B):715-22.

(3) Burstein HJ. The distinctive nature of HER-2 positive breast cancers. N Eng J Med. 2005;353(16):1652-54.

(4) Rusnak DW, Affleck K, Cockerill SG, Stubberfield C, Harris R, Page M, Smith KJ, Guntrip SB, Carter MC, Shaw RJ, Jowett A, Stables J, Topley P, Wood ER, Brignola PS, Kadwell SH, Reep BR, Mullin RJ, Alligood KJ, Keith BR, Crosby RM, Murray DM, Knight WB, Gilmer TM, Lackey K. The characterization of novel, dual ErbB-2/EGFR, tyrosine kinase inhibitors: potential therapy for cancer. Cancer Res. 2001;61:7196- 203.

Additional reference available at: Moy B and Goss PE. Lapatinib: Current Status and Future Directions. Oncologist 2006; 11:1047-1057.


Source: GlaxoSmithKline

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