LONDON and PHILADELPHIA, May 24 /PRNewswire-USNewswire/ -- GlaxoSmithKline will present a breadth of new data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago starting Friday, June 1st, on a wide range of innovative cancer treatments, experimental medicines and vaccines spanning more than ten prevalent cancer types.
GSK will make 30 data presentations at ASCO including 18 for TYKERB(R)/TYVERB(TM) (lapatinib), which is approved in the U.S. in combination with capecitabine (Xeloda(R)) 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, and which was approved this week in Switzerland. GSK will also present data for other approved products and several investigational medicines, including the investigational oral angiogenesis inhibitor, pazopanib, the investigational MAGE-A3 cancer immunotherapy, and the cervical cancer candidate vaccine, CERVARIX(R), which was recently approved in Australia.
Highlights of the data to be presented at ASCO include: (For more information, please go to http://www.ASCO.org)
Breast Cancer -- Dr. Charles E. Geyer, Allegheny General Hospital, Pittsburgh, PA, Abstract #1035, Poster Discussion, Saturday, June 2, 8:00 a.m. - 1:00 p.m., S403 and S406, Vista Room -- Dr. Angelo Di Leo, Hospital of Prato, Prato, Italy, Abstract #1011, Oral Presentation, Sunday, June 3, 11:00 a.m. - 11:15 a.m., N Hall B1 -- Dr. Nancy U. Lin, Harvard Medical School, Boston, MA, Abstract #1012, Oral Presentation, Sunday, June 3, 11:15 a.m. - 11:30 a.m., N Hall B1 -- Dr. Anna M. Storniolo, Indiana University Cancer Center, Indianapolis, IN, Abstract #514, Oral Presentation, Monday, June 4, 9:30 a.m. - 9:45 a.m., E Hall D1 Renal Cell Cancer -- Dr. Thomas E. Hutson, Baylor-Sammons/Texas Oncology PA, Dallas, TX, Abstract #5031, Poster Discussion, Saturday, June 2, 8:00 a.m. - 1:00 p.m., S103a and S100b Gynecologic Cancers -- Dr. Michael Friedlander, Prince of Wales Hospital, Sydney, Australia, Abstract #5561, Poster Session, Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2 -- Dr. Thomas W. Malpass, Virginia Mason Medical Center, Seattle, WA, Abstract #5570, Poster Session, Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2 -- Dr. Jalid Sehouli, Medical Faculty of Humboldt University, Berlin, Germany, Abstract #5526, Poster Session, Sunday, June 3, 8:00 a.m. - 12:00 p.m., E451a and E354a Soft Tissue Sarcoma -- Dr. Stefan Sleijfer, Erasmus University Medical Center, Rotterdam, The Netherlands, Abstract #10031, Poster Discussion, Monday, June 4, 2:00 p.m. - 6:00 p.m., S103a and S404 Non-Small Cell Lung Cancer -- Dr. Johan F. Vansteenkiste, University Hospital Gasthuisberg, Leuven, Belgium, Abstract #7554, Poster Discussion, Tuesday, June 5, 8:00 a.m. - 12:00 p.m., E451a and E354a Cervical Cancer Vaccine -- Dr. Tino F. Schwarz, Stiftung Juliusspital, Wuerzburg, Germany, Abstract #3007, Oral Presentation, Tuesday, June 5, 8:45 a.m. - 9:00 a.m., E354a Non-Hodgkin’s Lymphoma -- Dr. Christopher R. Flowers, Emory University School of Medicine, Atlanta, GA, Abstract #8089, Poster Session, Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2 -- Dr. Julie Vose, University of Nebraska Medical Center, Omaha, NE, Abstract #8013, Oral Presentation, Sunday, June 3, 11:00 a.m. - 11:15 a.m., E354b -- Dr. Mark S. Kaminski, University of Michigan Health System, Ann Arbor, MI Abstract #8033, Poster Discussion, Monday, June 4, 2:00 p.m. - 6:00 p.m., E451a and E354b Small Cell Lung Cancer -- Dr. Mary E. O’Brien, Royal Marsden Hospital, Sutton, Surrey, United Kingdom, Abstract #7725, Poster Session, Sunday, June 3, 8:00 a.m. - 12:00 p.m., S Hall A2
Important Safety Information
TYKERB (lapatinib), in combination with capecitabine, is approved by the FDA 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.
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 preexisting 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.
TYKERB prolongs the QT interval in some patients. Consider ECG and electrolyte monitoring.
Diarrhea was the most common adverse event resulting in discontinuation of study medication. Proactive management of diarrhea with antidiarrheal 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.
A dose reduction should be considered for patients with severe hepatic impairment.
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%) during treatment with TYKERB plus capecitabine were diarrhea, vomiting, nausea, fatigue, palmar-plantar erythrodysesthesia, and rash.
Notes to editors:
GlaxoSmithKline (GSK) is one of the world’s leading pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Collaboration is a fundamental part of how GSK achieves its commitment to a broad spectrum of cancer care. GSK has partnered with over 160 of the leading cancer centers worldwide and is committed to these partnerships to promote breakthrough work in the field of oncology. For more information visit http://www.gsk.com.
TYKERB(R) is a registered trademark of the GlaxoSmithKline group of companies in the United States.
TYVERB(TM) is a registered trademark of the GlaxoSmithKline group of companies in Europe.
CERVARIX(R) is a registered trademark of the GlaxoSmithKline group of companies.
Xeloda(R) is a registered trademark of Roche Pharmaceuticals.
Cautionary statement regarding forward-looking statements
Under the safe harbour 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 ‘Business Review’ in the company’s Annual Report on Form 20-F for 2006.
Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Joss Mathieson (020) 8047 5502 Gwenan White (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Alice Hunt (215) 751 7709 European Analyst/Investor Anita Kidgell (020) 8047 5540 enquiries: Sally Ferguson (020) 8047 5542 David Mawdsley (020) 8047 5564 US Analyst/ Investor Frank Murdolo (215) 751 7002 enquiries: Tom Curry (215) 751 5419 For on-site contact at ASCO 1-5 June 2007: Liad Diamond -- CERVARIX, US media only +1 215 990 5888 Stella Gu -- CERVARIX, global media only +32 472 902 710 Robin Fastenau -- Pazopanib and TYVERB global media +1 919 522 5237 Sarah Alspach -- TYKERB, Hycamtin, BEXXAR US media only +1 215 287 6354
GlaxoSmithKline
CONTACT: US media only: Liad Diamond (CERVARIX), +1-215-990-5888, SarahAlspach (TYKERB, Hycamtin, BEXXAR), +1-215-287-6354, or Global media only:Stella Gu (CERVARIX), +32 472 902 710, Robin Fastenau (Pazopanib andTYVERB), +1-919-522-5237, all of GlaxoSmithKline
Web site: http://www.gsk.com/http://www.ASCO.org/
