Navigation Links
GSK Study Showed Targeted Therapy Combination Achieved 14 Month Overall Survival in Patients with Advanced Breast Cancer

LONDON and PHILADELPHIA, Dec. 11 /PRNewswire/ -- In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). The results of the Phase III study in HER2-positive metastatic breast cancer were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (Dec. 9 - 13).

The study included 296 women with a type of breast cancer known as HER2-positive disease, characterized by an overexpression of the HER2 protein in the cancer cells. Patients enrolled in the study experienced recurrence of breast cancer despite a median of three prior trastuzumab-based therapies. The data presented at the San Antonio congress showed that patients overcame resistance to trastuzumab with the introduction of the lapatinib-trastuzumab combination.

"The clinical benefits brought forth by the lapatinib and trastuzumab combination are quite compelling and lead me to believe the agents may be acting together to form a sort of 'dual blockade' to obstruct the HER2 pathway necessary for the tumor to thrive," said primary investigator, Kimberly Blackwell, M.D., Duke University Medical Center.

Patients in the study were randomized to receive single agent lapatinib (1500 mg/daily) or a combination of lapatinib (1000 mg p.o. daily) plus trastuzumab (2 mg/kg). For those patients treated with monotherapy lapatinib, cross-over to the combination was allowed if the disease progressed after at least four weeks of therapy. Final analysis showed clinical activity for lapatinib in the control arm. Women treated with monotherapy lapatinib experienced a median overall survival of 9.5 months compared with 14 months when treated with the combination (median HR: 0.74, p=0.026).

"It's possible that, by lapatinib working inside the cell and trastuzumab working outside the cell, the combination of agents is able to provide a more complete anti-tumor attack," said Blackwell. "To achieve a survival advantage of greater than one year for this aggressive form of breast cancer is very encouraging."

Final safety analysis showed the incidence of adverse events were similar among both treatment groups with the exception of the incidence of grade 1 and 2 diarrhea, which was significantly higher in the combination group (P = 0.03). The incidence of grade 3 or higher AEs was similar among treatment groups (7%).The most common adverse events (incidence greater than or equal to 10%) were diarrhea, nausea, rash, fatigue and vomiting. Of the Grade 3/4 adverse events observed, cardiac events were reported in three patients on the combination arm and in one patient on the monotherapy arm. One patient in the combination arm experienced cardiac failure and later died due to pulmonary thromboembolism that was caused by disease progression and/or study medication.

"Very few clinical studies have shown a survival benefit in metastatic breast cancer," said Steven Stein, M.D., Vice President, Medicine Development, GSK Oncology. "It's very encouraging to see the results gained by combining these two agents."

TYKERB is currently indicated in combination with Xeloda® (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 Herceptin (trastuzumab). TYKERB alone or in combination with HERCEPTIN is not approved in this setting.

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. For company information, visit GlaxoSmithKline at

To access the latest GSK news, visit

BOXED WARNING and Additional Important Safety Information

Hepatotoxicity - TYKERB has been associated with hepatotoxicity. Hepatotoxicity (ALT or AST >3 times the upper limit of normal and total bilirubin >1.5 times the upper limit of normal) has been observed in clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with TYKERB should be discontinued and patients should not be re-treated with TYKERB.

Decreased Left Ventricular Ejection Fraction - TYKERB has been reported to decrease 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. Confirm normal LVEF before starting TYKERB, and continue evaluations during treatment.

Patients with Severe Hepatic Impairment - If TYKERB is to be administered to patients with severe hepatic impairment, dose reduction should be considered.

Diarrhea - Diarrhea, including severe diarrhea, has been reported during treatment with TYKERB and was the most common adverse reaction resulting in discontinuation of TYKERB therapy. 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.

Interstitial Lung Disease/Pneumonitis - TYKERB has been associated with interstitial lung disease and pneumonitis. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease or pneumonitis and if symptoms are greater than or equal to Grade 3 (NCI CTCAE), TYKERB should be discontinued.

QT Prolongation - TYKERB prolongs the QT interval in some patients. TYKERB should be administered with caution to patients who have or may develop prolongation of QTc. Hypokalemia or hypomagnesemia should be corrected prior to TYKERB administration. Baseline and on-treatment electrocardiograms with QT measurement should be considered.

Pregnancy: Pregnancy D - TYKERB can cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant when taking TYKERB. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Adverse Reactions - The most common adverse reactions (>20%) during therapy with TYKERB plus capecitabine compared to capecitabine alone were diarrhea (65%, 40%), nausea (44%, 43%), vomiting (26%, 21%), palmar-plantar erythrodysesthesia (53%, 51%), rash (28%, 14%), and fatigue (46%, 47%).

The most common grade 3 and 4 adverse reaction (NCICTC v3) with TYKERB plus capecitabine compared to capecitabine alone were diarrhea (14%, 10%) and palmar-plantar erythrodysesthesia (12%, 14%).

Please see full prescribing information, including BOXED WARNING.

Notes to Editors:

TYKERB® is a registered trademark of the GlaxoSmithKline group of companies in the United States.

TYVERB® is a registered trademark of the GlaxoSmithKline group of companies in Europe.

XELODA® is a registered trademark of Roche Laboratories Inc.

HERCEPTIN® is a registered trademark of Genentech, Inc.

    Onsite Media Enquiries (US Media)     Ken Inchausti         (267) 809 7552
    Onsite Media Enquiries (ex-US Media)  Gregory Clarke        (610) 405 0053

    UK Media Enquiries:                   Philip Thomson       (020) 8047 5502
                                          David Outhwaite      (020) 8047 5502
                                          Stephen Rea          (020) 8047 5502

    US Media Enquiries:                   Nancy Pekarek         (919) 483 2839
                                          Mary Anne Rhyne       (919) 483 2839
                                          Kevin Colgan          (919) 483 2839
                                          Sarah Alspach         (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:        Tom Curry             (215) 751 5419
                                          Jen Hill Baxter       (215) 751 7002

    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.

    Registered in England & Wales:
    No. 3888792

    Registered Office:
    980 Great West Road
    Brentford, Middlesex
    TW8 9GS

SOURCE GlaxoSmithKline

SOURCE GlaxoSmithKline
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Genomic Health Announces Publication of Study of Oncotype DX(R) in Node-Positive Breast Cancer That Identifies Patients Who Do Not Appear to Benefit From Chemotherapy
2. Phase III CONFIRM Study Shows FASLODEX(R) (fulvestrant) Injection 500 mg May Delay Time of Disease Progression Over 250-mg Dose in Postmenopausal Women With Hormone Receptor-Positive Advanced Breast Cancer
3. DecisionView Launches StudyOptimizer(TM) 4
4. Phase III Study Demonstrates INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) Statistically Similar to RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection
5. OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months
6. Sangart, Inc. Initiates Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
7. Sangamo BioSciences Announces Presentation of Preliminary Data From Phase 2 Study of SB-509 at International ALS Symposium
8. Final Data from Phase 2 Study Confirm High Response Rate of Micromets Blinatumomab in Patients with Acute Lymphoblastic Leukemia
9. Hemodynamic Therapeutics Announces Successful Completion of Initial Phase 2 Clinical Study for Novel Combination Hypertension Therapy
10. Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
11. ChemoCentryx Reports Additional New Data from the PROTECT-1 Study Demonstrating Traficet-ENs Effectiveness in Maintaining Remission in Patients with Crohns Disease
Post Your Comments:
(Date:11/25/2015)... -- Allergan plc (NYSE: AGN ), a ... start-up  biotechnology company focused on the development of ... by the F-Prime Biomedical Research Initiative (FBRI), today ... collaboration to support the discovery and development of ... Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... Israel , November 25, 2015 ... "New Investors"), pursuant to which BioLight and the New ... IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The ... of its innovative IOPtimate™ system used in the treatment ... approval pathway process for the IOPtimate™ system with the ...
(Date:11/25/2015)... , Nov. 25, 2015 Research and ... the "Membranes Market - Global Forecast to 2020" ... Asia-Pacific , accounting for 37.21% of the total ... Asia-Pacific region is projected to growth ... growth has been attributed primarily to the fast growing ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, officials ... the Narconon network, announced the release of a new cutting edge recovery program that ... has been working with drug- and alcohol-addicted individuals with the purpose to free addicts ...
(Date:11/25/2015)... , ... November 25, 2015 , ... Smiles by ... TMJ Disorder, Bruxism, and moderate facial wrinkling. While many patients are aware of the ... the great success Botox® delivers to those suffering with discomfort, soreness, and pain as ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted ... in Chicago, IL, UV Angel is evaluating the efficacy of its product and its ... units (totaling 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, ...
(Date:11/25/2015)... ... 25, 2015 , ... In honor of Pulmonary Hypertension Awareness ... groups responsible for advancing care for pulmonary hypertension (PH) patients and helping to ... will receive special recognition throughout 2016 as part of PHA’s 25th anniversary celebrations. ...
(Date:11/25/2015)... MA (PRWEB) , ... November 25, 2015 , ... Many ... — fatigue, fuzzy-headedness, weight gain, cold hands, and dry skin. But many people who ... their diet and exercise regimen instead of their thyroid, especially if they don’t have ...
Breaking Medicine News(10 mins):