3rd Apr 2006 14:02
GlaxoSmithKline PLC03 April 2006 Issued - Monday 3 April 2006 GlaxoSmithKline Receives Positive Data and Halts Enrolment in Phase iii Trial ofTykerb(R) (Lapatinib) in Advanced Breast Cancer First Regulatory Filings now Planned for 2nd Half of 2006 Based on the unanimous recommendation of an Independent Data MonitoringCommittee (IDMC), GlaxoSmithKline (GSK) announced today that it has haltedenrolment in its Phase III clinical trial evaluating the combination of Tykerb(lapatinib ditosylate) and capecitabine (Xeloda(R)) versus capecitabine alone.The trial evaluated women with refractory advanced or metastatic breast cancerwho have documented ErbB2 (HER2) overexpression and whose disease progressedfollowing treatment with trastuzumab (Herceptin(R)) as well as other cancertherapies. A pre-planned interim analysis of 321 patients in the study yieldedstatistically significant results, exceeding the primary endpoint. According to the study protocol, the pre-planned interim analysis was reviewedby the IDMC, which is comprised of medical oncology experts and a statistician.The IDMC unanimously recommended halting enrolment in the study because itexceeded its primary endpoint of time to disease progression, or TTP, for womenreceiving the combination of Tykerb and capecitabine. The IDMC made theirrecommendation based on pre-specified stopping rules outlined in their charter.All women currently enrolled in the trial will continue to be followed and thosewho are receiving capecitabine alone will be offered the option of switching tothe combination therapy of capecitabine and Tykerb in consultation with theirphysician. "We are extremely encouraged by these data which suggest that Tykerb may offersignificant benefit as an oral medication in combination with chemotherapy forpatients with advanced or metastatic ErbB2 positive breast cancer, and whosedisease has progressed on previous treatment regimens, including Herceptin,"said Paolo Paoletti, M.D., Senior Vice President of the Oncology MedicineDevelopment Center, at GSK. "On the basis of this and other data we now plan tofile in the US and Europe during the second half of 2006." The Phase III trial (EGF100151) is an international, multicentre, randomised,open-label study to evaluate and compare TTP in patients with documented ErbB2(HER2) overexpressing refractory advanced or metastatic breast cancer treatedwith Tykerb in combination with capecitabine versus capecitabine alone. Theprimary endpoint of the study was to detect a 50 percent increase in TTP in thecombination arm compared with the capecitabine alone arm. 392 patients have beenenrolled in the study of which 321 were included in the analysis (160 in thecombination arm and 161 in the monotherapy arm). The most common drug-relatedadverse events in the combination arm of the study were diarrhea and nausea. Tykerb is an experimental drug that does not have regulatory approval in anycountry for any use outside of clinical trials. S M Bicknell Company Secretary 3 April 2006 About Metastatic Breast Cancer The World Health Organization reports that just over one million cases of breastcancer are diagnosed annually. Breast cancer is the most common non-cutaneousmalignancy in women and one of the leading causes of cancer death. Approximately 10-20 percent of newly diagnosed breast cancer patients havelocally advanced and/or metastatic disease; 20 to 85 percent of patients(depending on initial stage, tumor biology, and treatment strategy) diagnosedwith early breast cancer will develop recurrent and/or metastatic disease.1 Themedian survival time for women treated for metastatic breast cancer is twoyears.2 About Tykerb Tykerb, a small molecule that is administered orally, inhibits the tyrosinekinase components of ErbB1 and ErbB2 receptors. Stimulation of ErbB1 and ErbB2is associated with cell proliferation and with multiple processes involved intumor progression, invasion, and metastasis. Overexpression of these receptorshas been reported in a variety of human tumors and is associated with poorprognosis and reduced overall survival. GSK is using advanced technologies,including pharmacogenetics, to better define patient populations that mayrespond to Tykerb. Tykerb is being developed by GSK as an orally administered therapy for breastcancer and other solid tumors. About GlaxoSmithKline GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies is committed to improving the quality of human life byenabling people to do more, feel better, and live longer. For companyinformation, visit GlaxoSmithKline at http://www.gsk.com. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the US Private Securities Litigation ReformAct of 1995, the company cautions investors that any forward-looking statementsor projections made by the company, including those made in this Announcement,are subject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect the Group's operationsare described under 'Risk Factors' in the Operating and Financial Review andProspects in the company's Annual Report on Form 20-F for 2005. Notes to editors: Tykerb(R) (lapatinib) is also designated as GW572016. Tycerb(R) (lapatinib) is the registered trade name of lapatinib in Europe. Herceptin(R) is a registered trademark of Genentech, Inc. in the United Statesand Roche Pharmaceuticals in Europe. Xeloda(R) is a registered trademark of Roche Pharmaceuticals. References: 1 C. Bernard-Marty et al. Facts and Controversies in Treatment of Systemic Metastatic Breast Cancer. The Oncologist. 2004:9:617-632. 2 ibid. Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Alice Hunt (020) 8047 5502 Gwenan Evans (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542 Jen Hill (020) 8047 5543 David Mawdsley (020) 8047 5564 US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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