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GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)

Highlights Include:

-- Results demonstrating that TYKERB and trastuzumab together resulted in a clinically meaningful extension of progression-free survival (PFS)

-- Combining TYKERB and trastuzumab to attack both the inside and outside of the HER2 receptor may create a more complete HER2 blockade

-- Data demonstrating activity of TYKERB alone despite patients' previous treatment with multiple lines of trastuzumab and chemotherapy

LONDON and PHILADELPHIA, May 16 /PRNewswire-USNewswire/ -- GlaxoSmithKline today announced positive data from the first-ever randomized, multi-center, open label Phase III trial of the combination of two targeted agents, TYKERB and trastuzumab, in women with HER2-positive metastatic breast cancer (1). HER2-positive breast cancer is a particularly aggressive form of cancer that affects approximately 25 to 30 percent of breast cancer patients (2). The study results demonstrated a benefit from the combination. Both treatments target the HER2 (ErbB2) protein but work in different ways (1). Trastuzumab attaches to the outside of the HER2 protein, while TYKERB goes inside the cell to block signals from the HER2 protein for the cancer to grow (3). GlaxoSmithKline Oncology will present these and other new data in breast cancer at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago beginning Friday, May 30th.

"Many women with HER2 positive breast cancer are still very active and living full lives, yet when their disease progresses after trastuzumab and chemotherapy, we have had limited treatment options. Therefore it is important to study options that may eventually help women in their fight against this disease," said lead investigator Joyce O'Shaughnessy, M.D., Baylor-Sammons Cancer Center, Texas Oncology, PA, US Oncology, Dallas, TX. "Effectively attacking HER2 from multiple angles is an exciting and innovative approach, and demonstrates the significant advances being achieved in treating this complex form of breast cancer."

Despite receiving multiple prior lines of anti-cancer therapy, patients who received TYKERB plus trastuzumab in this study experienced:

-- A statistically significant increase in median progression-free survival

versus TYKERB alone (12 weeks vs. 8.1 weeks) (1)

-- A 27 percent reduction in the risk of disease progression [Hazard Ratio:

0.73; p=0.008] (1)

-- A response rate of 10.3 percent versus 6.9 percent. Response rate is a

clinical term that is calculated by complete and partial disappearance

of the tumor.

-- Double the overall clinical benefit rate versus TYKERB alone (24.7

percent vs. 12.4 percent; p=0.01) (1). Clinical benefit rate is

calculated by the response rate and the rate of durable stable disease

(greater than or equal to 6 months).

-- A trend in improved overall survival [Hazard Ratio: 0.75; p=0.106] (1)

The study also demonstrated the activity of TYKERB as a single agent in this patient population, with patients on this arm achieving a median progression free survival of 8.1 weeks and an overall clinical benefit rate of 12.4 percent (1).

The clinical synergy of TYKERB and trastuzumab confirms previous observational findings in preclinical studies and previously reported data from a Phase I study. These latest findings confirm the rationale for further research of this combination in earlier lines of therapy in the metastatic setting and in early stage disease. Additional analysis is underway to explore the benefit that TYKERB plus trastuzumab can offer to less heavily pre-treated patients (1).

Study Background

In this study, 296 patients with HER2 positive breast cancer who had documented progression on trastuzumab treatment in the metastatic setting were eligible to be randomized to receive TYKERB (1000 mg QD) plus trastuzumab (2 mg/kg weekly after 4 mg/kg loading dose) or TYKERB alone (1500 mg QD). Patients were heavily pre-treated and had received a median of six prior anti-cancer regimens. Patients had received a median of three prior lines of trastuzumab (1).

The primary endpoint of the study was progression-free survival, and secondary endpoints included clinical benefit rate (CR+PR+SD greater than or equal to 24 weeks), response rate, and overall survival. If patients progressed on the TYKERB monotherapy arm after four weeks of therapy, they could cross over to receive the combination of TYKERB + trastuzumab. Adverse events were similar in both arms, with Grade 1/2 diarrhea higher in the TYKERB + trastuzumab arm (53 percent vs. 41 percent; p=0.03). Two patients in the combination arm and one patient in the TYKERB monotherapy arm experienced symptomatic decreases in left ventricle ejection fracture (LVEF); one patient in the TYKERB + trastuzumab arm died due to a pulmonary thromboembolism with progressive malignant pleural effusions; two patients with LVEF decrease later recovered. Isolated cases of asymptomatic transient decreases in LVEF were noted in both treatment arms (1).

Additional Breast Cancer Data for Investigational Uses of TYKERB to be Presented at ASCO

GSK Oncology will also be presenting for the first time results of two studies evaluating TYKERB in combination with other targeted therapies, including TYKERB + pazopanib, GSK's investigational, oral, multikinase angiogenesis inhibitor, and TYKERB + bevacizumab. Final results from a trial evaluating TYKERB monotherapy in inflammatory breast cancer (IBC) will also be presented on-site. For more information on date and time of presentation, visit

"The breadth of data to be presented at ASCO this year is truly remarkable and signifies the commitment of GSK Oncology to being at the forefront of cancer research," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "We are excited by all of the results that will be presented and the promise they hold for the cancer community."

Available Online

For additional information on GSK's Oncology portfolio or the data being presented at ASCO, including detailed product fact sheets and press releases, visit This information will be updated throughout the ASCO annual meeting. Please also see onsite contact information listed at the end of this release.


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. TYVERB recently received a positive opinion from the Committee for Medical Products for Human Use (CHMP) of Europe. Marketing authorization in Europe is pending.

GSK in Oncology

GSK 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. For more information about GSK Oncology, visit

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. To access the latest GSK Oncology media materials, visit For more information about GSK Oncology, visit

TYKERB 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 in the United States.

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. TYVERB is currently not licensed in Europe.

HERCEPTIN(R) is a registered trademark of Genentech, Inc.

For on-site contact at ASCO 30 May - 3 June 2008:

U.S media only: Sarah Alspach - +1 215 287 6354

Global media: Gregory Clarke - +1 317 694 3545

European media: Sonja Luz - +44 792 056 8625


US Media enquiries: Mary Anne Rhyne +1 919 483 2839

UK Media enquiries: Philip Thomson +44 20 8047 5502

Gwenan White +44 20 8047 5502

Alice Hunt +44 20 8047 5502

European Analyst/

Investor enquiries: David Mawdsley +44 20 8047 5564

Sally Ferguson +44 20 8047 5543

Gary Davies +44 20 8047 5503

US Analyst/Investor enquiries: Frank Murdolo +1 215 751 7002

Tom Curry +1 215 751 5419


1. O'Shaughnessy J, et. al. Final presentation for abstract #1015 - A

randomized study of lapatinib (TYKERB(R)) in combination with trastuzumab

vs. lapatinib monotherapy in heavily pretreated HER2-positive metastatic

breast cancer progressing on trastuzumab therapy. To be presented at the

2008 American Society of Clinical Oncology annual meeting.

2. "Glossary." American Cancer Society.

=. Accessed May 7, 2008.

3. Geyer C, et. al. Lapatinib plus capecitabine for HER2-positive advanced

breast cancer. N Engl J Med 2006;355:2733-43.

SOURCE GlaxoSmithKline
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