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Research Findings on Nine GlaxoSmithKline Cancer Compounds to be Presented at ASCO 2009

May 11, 2009

Data Include First Presentation of Phase III Progression Free Survival Results for Pazopanib in Kidney Cancer

LONDON and PHILADELPHIA, May 11 /PRNewswire/ — GlaxoSmithKline (GSK) Oncology announced that new clinical data from nine of its oncology molecules will be featured in various presentations at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando beginning May 29. The presentations cover GSK Oncology research in solid and blood tumor treatment, supportive care and prevention in an array of difficult to treat tumors including kidney cancer, advanced breast cancer, leukemia and prostate cancer.

The following investigational presentations reflect the broad spectrum of GSK-sponsored studies being presented at this year’s ASCO Congress:

Kidney Cancer: New, pivotal Phase III data surrounding the GSK oral, investigational, angiogenesis/VEGF inhibitor, pazopanib. Also, Phase II data on GSK089, a new investigational compound with a MET/VEGFR2 mechanism of action.

  • ORAL PRESENTATION: “A randomized, double-blind Phase III study of pazopanib in treatment naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC).” Dr. C. Sternberg, San Camillo and Forlanini Hospitals, Italy; Presentation on June 1.
  • “A Phase II study of 2 dosing regimens of GSK 1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in patients (pts) with papillary renal carcinoma (PRC).” Dr. R. Srinivasan, National Cancer Institute; Poster presentation on May 31.

Gastric Cancer: Investigational Phase II study exploring GSK089 in gastric cancer.

  • ORAL PRESENTATION: “Assessment of 2 dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study.” Dr. M. A. Shah, Memorial-Sloan Kettering Cancer Center; Presentation on May 30.

Breast Cancer: Investigational data on new biomarkers in TYKERB(R)/TYVERB(R) (lapatinib) based treatment.

  • “cMET expression in Her2+ MBC patients with first-line lapatinib (L) treatment.” Dr. Y. Liu, GlaxoSmithKline, Collegeville, PA; Poster presentation on June 1.
  • “Clinical benefit of lapatinib-based therapy in patients with HER2-positive breast tumors expressing p95HER2.” Dr. L. Prudkin, Vall d’Hebron University Hospital, Barcelona, Spain; Poster presentation on June 1.

Leukemia: Data from the Phase III trial for the investigational compound, ofatumumab, in advanced stage blood cancer.

  • “Ofatumumab, a novel CD20 mAB, is active regardless of prior rituximab exposure in patients with fludarabine-and alemtuzumab-refractory or bulky fludarabine-refractory chronic lymphocytic leukemia (CLL).” Dr. W. Wierda, MD Anderson, the University of Texas MD Anderson Cancer Center; Poster presentation on May 30.

Other Investigational GSK Data

Data on the following compounds will also be presented at ASCO 2009: AVODART(R) (dutasteride), elesclomol, eltrombopag, topotecan and GSK923925.

About TYKERB(R)/TYVERB(R) (lapatinib)

Lapatinib is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor. Stimulation of HER2/ErbB2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

Lapatinib, in combination with capecitabine, is authorized in 74 countries. On March 13, 2007, the U.S. FDA approved lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2/ErbB2 and who have received prior therapy including an anthracycline, a taxane and trastuzumab. On June 10, 2008, the European Commission granted a conditional marketing authorization for lapatinib in all 27 European Union (E.U.) member states. Other countries in which lapatinib is authorized for marketing include Japan, Australia, India, Brazil, Russia, Switzerland, Turkey, South Korea, Taiwan and others around the world. Registration dossiers for lapatinib have been filed in Canada, China, Mexico and a number of countries in Latin America, Middle East, Africa and Asia Pacific.

For more information see full prescribing information.

About AVODART(R) (dutasteride)

Dutasteride inhibits both type 1 and type 2 5-alpha reductase isoenzymes, which are responsible for converting testosterone to dihydrotestosterone (DHT), the most potent male hormone in the prostate. Basic science studies indicate that both types of the enzyme – type 1 and type 2 – are present in prostate tissue and that the type 1 form is increased in prostate cancer, including high grade cancer. The clinical significance of the in vitro dual inhibition of type 1 and type 2 5-alpha reductase isoenzymes has not been established.

Dutasteride is indicated for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It has been shown to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and the risk of BPH-related surgery.

Women and children should not take dutasteride. Women who are or could become pregnant should not handle dutasteride due to the potential risk of a specific birth defect. Blood should not be donated until at least six months following the last dose of dutasteride. Possible side effects include sexual side effects and swelling or tenderness of the breast.

Dutasteride is not approved or licensed to treat or reduce the risk of prostate cancer.

For more information see full prescribing information.

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.

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 further information please visit www.gsk.com

TYKERB(R) is a registered trademark of the GlaxoSmithKline group of companies in the United States and the countries outside of Europe.

TYVERB(R) is a registered trademark of the GlaxoSmithKline group of companies in the European Union.

AVODART(R) is a registered trademark of the GlaxoSmithKline group of companies in the United States and the countries outside of Europe.

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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 2008.

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SOURCE GlaxoSmithKline


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