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TYKERB(R) (Lapatinib) to be Investigated in Landmark Early Breast Cancer Trial

PHILADELPHIA, May 12 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK), in collaboration with the Breast International Group (BIG), a leading academic breast cancer research network, and one of its member groups, the Spanish Breast Cancer Cooperative Group (SOLTI), today announced the start of a global Phase III study that will examine the role of TYKERB(R) in the treatment of early breast cancer. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization) will evaluate and compare the rate at which cancer cells disappear in the breast following treatment with TYKERB and/or trastuzumab before surgery in women with early-stage HER2-positive breast cancer. This type of treatment is referred to as neo-adjuvant therapy. TYKERB is an investigational drug and has not yet been approved for this indication.

"The evolution seen in breast cancer care has been tremendous in the last few decades," said Dr. Jose Baselga, Co-Chair on Neo-ALTTO and Chair of the SOLTI Group, Spain. "Surgery, in the form of a radical mastectomy of the breast, was traditionally the first line treatment offered to patients with little or no improvement in overall survival. Now we have a range of sophisticated targeted treatments that can significantly delay disease progression and increase survival. Through trials such as Neo-ALTTO, oncologists may be better able to optimize the use of these agents."

One in four women diagnosed with early breast cancer have tumors that are HER2-positive.(1) It is well recognized that these women have a higher risk of their cancer returning - either at the location of the original tumor or when the cancer spreads to other organs - even after receiving additional therapies.(1)

"The launch of Neo-ALTTO is extremely exciting as this study will help physicians answer important clinical questions relating to the neoadjuvant treatment regimen of HER2-positive breast cancer," said Dr. Martine Piccart, Chairperson of the Breast International Group, Institute Jules Bordet, Brussels, and investigator on Neo-ALTTO. "All too often clinicians and patients face the problem of disease recurrence, and women with high levels of HER2 protein are at a greater risk of this occurring. It is vital that early stage breast cancer is treated effectively from the outset with the right combination or sequence of therapies."

Neo-ALTTO is a three-arm, randomized, multi-center, open-label Phase III study of neoadjuvant TYKERB, neoadjuvant trastuzumab and a combination of neoadjuvant TYKERB and trastuzumab in women with HER2-positive primary breast cancer. After treatment for six weeks, the same targeted therapy will be repeated for 12 weeks with the addition of paclitaxel. Surgery will be performed on all patients, after which each patient will receive three courses of chemotherapy followed by the same targeted therapy for 34 weeks.

The primary objective of Neo-ALTTO is to evaluate and compare the rate of pathological complete response (or complete eradication of the tumor) at the time of surgery as well as understand the biological difference of the three treatment regimens using a neoadjuvant approach. Secondary objectives include measurements of safety and tolerability, tumor response rate, disease-free survival and overall survival. Target enrollment is 450 patients with 130 clinical trial centers participating across 26 different countries.

It is hoped that Neo-ALTTO will lead to the discovery of new molecular biomarkers that help to better identify the benefits of TYKERB or trastuzumab.

"GSK is proud to collaborate with such esteemed research groups as BIG and SOLTI for the study of TYKERB in this early breast cancer setting," said Paolo Paoletti, MD, Senior Vice President, Oncology Medicines Development Center of GSK. "This important global Phase III study, which has been enrolling within a year of the FDA approval of TYKERB, demonstrates the confidence that the oncology community has in TYKERB and the importance of identifying the most effective treatment regimen for patients with early stage HER2-positive breast cancer."

Worldwide, breast cancer is by far the most frequent cancer affecting women, with over one million new cases each year; breast cancer is also the leading cause of female cancer-related deaths.(2) Approximately 20 to 85 percent of patients (depending on initial stage, tumor biology, and treatment strategy) diagnosed with early breast cancer will develop recurrent and/or metastatic disease.(3)

About BIG

The Breast International Group (BIG), based in Brussels, Belgium, is an international non-profit organization for academic breast cancer research groups from around the world. By encouraging interaction and cooperation between its members and related cancer networks, and by collaborating with, but working independently from, the pharmaceutical industry, BIG's mission is to facilitate the conduct of large and difficult breast cancer clinical trials and to reduce the wasteful duplication of efforts. Created by leading European opinion leaders in 1996, BIG now constitutes a network of 41 groups in Europe, Canada, Latin America, Australia/New Zealand and Asia. These research entities, which coordinate the BIG trials, are in turn tied to approximately 3,000 specialized hospitals and research centers round the world. In 2004, BIG founded a complementary network for translational research, which involves 40 partners in 22 countries and is partially supported by the European Commission; to optimize research collaboration globally, BIG has also forged strong ties with North American collaborative groups. Through these efforts BIG hopes ultimately to advance knowledge about breast cancer and better serve the women whose lives are affected by this disease.


SOLTI is a non-for-profit organization under Spanish law, made up of a network of around 30 medical oncology departments from some of the most important university hospitals across Spain and Portugal, with an operations office located near to Barcelona. SOLTI's mission is to encourage, design and develop clinical trials in breast cancer and in other solid tumours to answer relevant questions about cancer treatment. The group is involved in a number of multicentre, international clinical trials on breast cancer. Its partners are other international academic groups and pharmaceutical and research companies. SOLTI is the sponsor, or the representative of the sponsor, in both domestic and multinational Phase Ib to III trials. The performance of the network of oncologists at SOLTI ranks among the top of international cooperative groups, after benchmark trials such as HERA, SOFT, ECTO II, NOAH and AZURE, among others.

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

GSK in OncologyGSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary "bench to bedside" approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


TYKERB is an oral small-molecule inhibitor of the HER2 tyrosine kinase receptor. Stimulation of HER2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of this receptor has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival. On March 13, 2007, the United States Food and Drug Administration (FDA) approved TYKERB, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.(4) TYVERB recently received a positive opinion from the Committee for Medical Products for Human Use (CHMP) of Europe. Marketing authorization is pending.

Important Safety Information*

TYKERB has been associated with hepatotoxicity. The hepatotoxicity may be severe and deaths have been reported. Causality is uncertain. Patients should receive liver function tests before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. A dose reduction in patients with severe pre-existing hepatic impairment should be considered. Discontinue and do not restart TYKERB if patients experience severe changes in liver function tests.

As with other therapies for HER2 overexpression, TYKERB has been associated with reports of decreases in left ventricular ejection fraction (LVEF). Caution should be taken if TYKERB is to be administered to patients with pre-existing cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. LVEF should be evaluated in all patients prior to and during treatment with TYKERB.

Diarrhea was the most common adverse event resulting in discontinuation of study medication. Proactive management of diarrhea with anti-diarrheal agents is important, and severe cases of diarrhea may require administration of oral or intravenous electrolytes and fluids and interruption or discontinuation of therapy with TYKERB.

TYKERB has been associated with interstitial lung disease and pneumonitis. Discontinue TYKERB if patients experience severe pulmonary symptoms.

TYKERB prolongs the QT interval in some patients. Consider ECG and electrolyte monitoring.

Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking TYKERB.

The most common adverse events (>20 percent) during treatment with TYKERB plus capecitabine were diarrhea, vomiting, nausea, fatigue, palmar-plantar erythrodysethesia, and rash.

*Please see full prescribing information.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, 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 GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.

Notes to editors:

TYKERB(R) is a registered trademark of the GlaxoSmithKline group of companies.

TYVERB(R) is a registered trademark of the GlaxoSmithKline group of companies in Europe and is the proposed trade name in certain markets, pending regulatory approval.

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(1) Baselga J, et al. Adjuvant trastuzumab: a milestone in the treatment of HER-2-positive early breast cancer. The Oncologist. 2006;11 Suppl 1:4-12.

(2) Parkin DM, et al. Global cancer statistics, 2002. C A Cancer J Clin. 2005 Mar-Apr;55(2):74-108.

(3) C. Bernard-Marty et al. Facts and Controversies in Treatment of Systemic Metastatic Breast Cancer. The Oncologist. 2004:9:617-632.

(4) TYKERB Prescribing Information, 2007.

SOURCE GlaxoSmithKline; Breast International Group; SpanishBreast Cancer
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