New Data For Presentation At ASCO 2008
LONDON and PHILADELPHIA, April 22 /PRNewswire/ -- GlaxoSmithKline Oncology will present a wide range of new data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago starting Friday, May 30th. The data cover a variety of therapies, experimental medicines and immunotherapeutics for the treatment and supportive care of cancer patients. At this year's ASCO meeting, GSK Oncology will present data that demonstrate trends in cancer research, including the combination of targeted therapies and a focus on oral treatment options.
GSK will make data presentations for TYKERB(R) (lapatinib), which is approved in more than 20 countries, including the US. The US indication is 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.
New data will also be presented for HYCAMTIN(R) (topetecan HCl). GSK will also present data for several investigational medicines, including the oral multikinase angiogenesis inhibitor, ARMALA(TM) (pazopanib); the neurokinin-1 receptor antagonist, REZONIC(TM) (casopitant); the oxidative stress inducer, elesclomol and the antigen-specific cancer immunotherapeutic, MAGE-A3 ASCI.
Highlights of the GSK Oncology data to be presented at ASCO include:
Breast Cancer
-- A randomized study of lapatinib (TYKERB) in combination with
trastuzumab vs. lapatinib monotherapy in heavily pretreated HER2+
metastatic breast cancer progressing on trastuzumab therapy [Phase
III]
-- Dr. Joyce O'Shaughnessy, Baylor-Sammons Cancer Center, Texas
Oncology, PA, US Oncology, Dallas, TX, abstract # 1015, oral
presentation, Sunday, June 01, 2008, 9:15 am - 9:30 am, E-Hall D1
-- Randomized study of pazopanib + lapatinib vs. lapatinib alone in
patients with HER2+ advanced or metastatic breast cancer [Phase II]
-- Dr. Dennis Slamon, UCLA Jonsson Comprehensive Cancer Center, Los
Angeles, CA, abstract # 1016, oral presentation, Sunday, June 01,
2008, 9:30 am - 9:45 am, E-Hall D1
-- A phase II evaluation of lapatinib (L) and bevacizumab (B) in HER2+
metastatic breast cancer (MBC)
-- Dr. Hope Rugo, UCSF Comprehensive Cancer Center, San Francisco,
CA, abstract # 1042, poster discussion, Tuesday, June 3, 11:00 am
- 12:00 pm, E Hall 354a; (poster presentation 8:00 am - 12:00 pm,
E Hall 450B)
-- Clinical activity of lapatinib monotherapy in patients with HER2+
relapsed/refractory inflammatory breast cancer (IBC): final results of
the expanded HER2+ cohort in EGF103009 [Phase II]
-- Dr. Bella Kaufman, The Chaim Sheba Medical Center, Tel Hashomer,
Israel, abstract # 636, poster presentation, Monday, June 02,
2008, 2 pm - 6 pm, S-Hall A1
Melanoma
-- Phase II trial of elesclomol* (formerly STA-4783) and paclitaxel in
stage IV metastatic melanoma (MM): Subgroup analysis by prior
chemotherapy
-- Dr. David Lawson, Emory University, abstract # 9036, poster
presentation, Saturday, May 31, 2008, 2 pm - 6 pm, S-Hall A1
-- Immunization with recombinant MAGE-A3 protein combined with adjuvant
systems AS15 or AS02B in patients with unresectable and progressive
metastatic cutaneous melanoma: a randomized open-label phase II study
of the EORTC Melanoma Group (16032-18031)
-- Dr. Wim Kruit, Erasmus Medical Center, Rotterdam, Netherlands,
abstract # 9065, poster presentation, Saturday, May 31, 2008, 2 pm
- 6 pm, S-Hall A1
Chemotherapy-Induced Nausea and Vomiting (CINV)
-- Phase III results of a novel neurokinin-1 (NK-1) receptor antagonist,
casopitant: single oral and 3-day oral dosing regimens for
chemotherapy-induced nausea and vomiting (CINV) in patients (Pts)
receiving moderately emetogenic chemotherapy (MEC)
-- Dr. Steven Grunberg, Vermont Cancer Center at University of
Vermont and Fletcher Allen Health Care, abstract # 9540, poster
discussion, Friday, May 30, 5 pm - 6 pm, S 406 Vista Room; (poster
presentation 2 pm - 6 pm, S403)
-- Phase III results for the novel neurokinin-1 (NK-1) receptor
antagonist, casopitant: single oral dosing regimen for
chemotherapy-induced nausea and vomiting (CINV) in patients (Pts)
receiving highly emetogenic chemotherapy (HEC)
-- Dr. Jorn Herrstedt, Department of Oncology, Herlev Hospital,
University of Copenhagen, Herlev, Copenhagen, Denmark, abstract #
9549, poster presentation, Saturday, May 31, 2 pm - 6 pm, S Hall
A1
Renal Cell Cancer (RCC)
-- Biomarker analysis and final efficacy and safety results of a phase II
renal cell carcinoma trial with pazopanib (GW786034), a multi-kinase
angiogenesis inhibitor
-- Dr. Thomas E. Hutson, Baylor-Sammons/Texas Oncology, PA, Dallas,
TX, abstract # 5046, poster discussion, Sunday, June 01, 2008, 11
am - 12 pm, W375a (poster presentation 8:00 am - 12:00 pm; W375e
Lobby)
Non-Small Cell Lung Cancer
-- Preoperative treatment with pazopanib (GW786034) a multikinase
angiogenesis inhibitor in early stage non-small cell lung cancer
(NSCLC): a proof-of-concept phase II study
-- Dr. Nasser Altorki, Weill Medical College of Cornell University,
abstract # 7557, poster presentation, Sunday, June 01, 2008, 2 pm
- 6 pm, S-Hall A1
Small Cell Lung Cancer
-- Topotecan (HYCAMTIN)/cisplatin (TP) compared to cisplatin/etoposide
(PE) for patients with extensive disease-small cell lung cancer
(ED-SCLC): final results of a randomized phase III trial
-- Dr. David Heigener, Krankenhaus Grosshansdorf, Grosshansdorf,
Germany, abstract # 7513, oral presentation, Sunday, June 01,
2008, 10:15 am - 10:30 am, W375e (oral session 8:00 am - 11:00 am;
W375e)
Important Safety Information for TYKERB
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.
Important Safety Information for HYCAMTIN
HYCAMTIN for Injection is used for the treatment of recurrent ovarian cancer.
HYCAMTIN for Injection is used for the treatment of small cell lung cancer that returns at least 2 months after completion of your first treatment.
HYCAMTIN for Injection plus cisplatin is used for the treatment of cervical cancer, if it is widespread when first diagnosed, doesn't go away with your first series of treatments, or comes back in a form that can't be cured with surgery or radiation.
Do not use if you have had an allergic reaction to HYCAMTIN for Injection, if you are pregnant, if you are breast-feeding, or if you have low blood counts.
HYCAMTIN for Injection can interfere with your body's ability to make white and red blood cells. In clinical studies, 78% of patients experienced low white blood counts and 37% of patients experienced low red blood cells. Your doctor may prescribe a supportive therapy to help your body make more blood cells. In clinical trials, side effects associated with HYCAMTIN for Injection when used alone included nausea (64%), vomiting (45%), diarrhea (32%), hair loss (49%), fatigue (29%), and shortness of breath (22%). Most of these side effects were mild to moderate.
In clinical trials, side effects associated with HYCAMTIN for Injection plus cisplatin when used to treat cervical cancer included low blood counts, pain (22%), vomiting (15%), nausea (14%), other digestive problems (14%), abnormal laboratory tests that may or may not cause symptoms (14%), and bladder/pelvic problems (12%).
Please 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.
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/.
Notes to editors:
TYKERB(R) is a registered trademark of the GlaxoSmithKline group of companies in the United States.
ARMALA(TM) is a trademark of the GlaxoSmithKline group of companies in the United States.
REZONIC(TM) is a trademark of the GlaxoSmithKline group of companies in the United States.
HYCAMTIN(R) is a registered trademark of the GlaxoSmithKline group of companies in the United States.
*Elesclomol is being developed under a global collaboration agreement between Synta Pharmaceuticals and GSK.
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.
Enquiries:
UK Media enquiries: Philip Thomson (020) 8047 5502
Gwenan White (020) 8047 5502
Alice Hunt (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
For on-site contact at ASCO 30 May - 3 June 2008:
U.S. media only: Sarah Alspach - TYKERB, ARMALA & elesclomol
+1 215 287 6354
Jeff McLaughlin - REZONIC +1 215 589 3774
Global media: Gregory Clarke - TYKERB/TYVERB, ARMALA &
elesclomol +1 317 694 3545
Garry Daniels - MAGE-A3 ASCI +32 477 03 16 13
European media: Sonja Luz - +44 792 056 8625
GlaxoSmithKline
