2008-04-18

Herceptin(R) Helps Eradicate HER2-Positive Breast Tumours When Given Before Surgery


BERLIN - European Breast Cancer Conference (EBCC), April 18(ots/PRNewswire) --

- For Non-UK and Non-US Media Only

- Herceptin Offers Women With HER2-Positive Breast Cancer theBest Chance of a Cure

New data presented today as part of a late breaking plenarysession at EBCC in Berlin showed that Herceptin (trastuzumab) incombination with standard chemotherapy prior to breast cancer surgery(neoadjuvant therapy) completely eradicates the tumours in 45.5% ofwomen with HER2-positive early breast cancer. This is an impressivefinding since the proportion of women achieving total tumoreradication with standard chemotherapy alone is less than 30%.(1)These important results from the GeparQuattro study highlight theefficacy of early treatment of HER2-positive breast cancer, raisingthe prospect of cure.

"Herceptin delivered on its promise of high tumour eradicationwhen given to women with this aggressive form of breast cancer beforetheir surgery", said investigator Prof. Dr. von Minckwitz, UniversityWomen's Hospital, Frankfurt, Germany and Managing Director of theGerman Breast Group. "The GeparQuattro study is the largestneoadjuvant clinical trial in women with HER2-positive breast cancerand shows that Herceptin offers real hope for women with early breastcancer."

The GeparQuattro results are consistent with other Herceptinneoadjuvant studies, such as NOAH (NeOAdjuvant Herceptin, including228 evaluable HER2-positive patients)(2) and TECHNO(Taxol-Epirubicin-Cyclophosphamid-Herceptin Neoadjuvant), reinforcingthe strong evidence for the benefits associated with Herceptin in theearly stages of HER2-positive breast cancer.

"It is very reassuring to see that the GeparQuattro studyconfirmed the significant benefits observed with Herceptin in otherneoadjuvant studies in HER2-positive breast cancer", commented Prof.Dr. Untch, Helios Clinics, Berlin, Germany, who presented the studyfindings. "Herceptin makes women with this aggressive type of breastcancer feel more confident about their future."

GeparQuattro and NOAH studied Herceptin in combination withdifferent chemotherapy regimens and showed equally good efficacyresults, indicating that Herceptin can be combined successfully withdifferent chemotherapies. Measuring the efficacy of Herceptin inthese studies was based on the disappearance of tumour cells in thebreast and in the lymph nodes - a therapeutic success measure knownas complete pathological response, which is a strong predictor forlong-term survival.(3),(4)

HER2-positive breast cancer is diagnosed in approximately 20-30%of all breast cancer cases.(5) It demands special attention becausethe tumours are typically fast-growing, and there is a highlikelihood of the cancer coming back. Pre-surgery therapy isadministered to women to help make large (>2cm) tumours shrinkenabling them to become operable and improve treatment outcomes.

Notes to Editors:

About the GeparQuattro study

GeparQuattro is a study conducted by the AGO and GBG studygroups. It is a randomized phase III study that enrolled 1510patients - 453 of the patients had HER2-positive disease. Patientswith HER2-positive breast cancer received four cycles of epirubicinplus cyclophosphamide plus Herceptin. Patients then received one ofthree treatment options: either four cycles of docetaxel plusHerceptin, docetaxel plus Xeloda plus Herceptin concomitantly, ordocetaxel plus Herceptin followed by Xeloda plus Herceptin.HER2-negative patients received the same chemotherapy regimen withoutadding Herceptin. The primary objective of the study was to assessthe efficacy of different chemotherapy regimens. One of the studyendpoints of GeparQuattro was pathological complete response rate(pCR) including in situ pathological response rate in patients withHER2-negative and HER2-positive disease. There were no significantcardiac events observed in the study.

About breast cancer

Breast cancer is the most common cancer among women worldwide.(6)Each year more than one million new cases of breast cancer arediagnosed worldwide, and nearly 400,000 people will die of thedisease annually.(7)

In HER2-positive breast cancer, increased quantities of the HER2protein are present on the surface of the tumour cells. This is knownas 'HER2-positivity.' High levels of HER2 are present in aparticularly aggressive form of the disease which responds poorly tochemotherapy. Research shows that HER2-positivity affectsapproximately 20-30 percent of women with breast cancer.

About Herceptin (trastuzumab)

Herceptin is a humanised antibody, designed to target and blockthe function of HER2, a protein produced by a specific gene withcancer-causing potential. It has demonstrated efficacy in treatingboth early and advanced (metastatic) breast cancer. Given on its ownas monotherapy as well as in combination with or following standardchemotherapy, Herceptin has been shown to improve response rates,disease-free survival and overall survival while maintaining qualityof life in women with HER2-positive breast cancer.

Herceptin received approval for use in the European Union foradvanced (metastatic) HER2-positive breast cancer in 2000, and forearly HER2-positive breast cancer in 2006. In the advanced setting,Herceptin is now approved for use as a first-line therapy incombination with paclitaxel where anthracyclines are unsuitable, asfirst-line therapy in combination with docetaxel, and as a singleagent in third-line therapy. It is also approved for use incombination with an aromatase inhibitor for the treatment ofpost-menopausal patients with HER2 and hormone receptor co-positivemetastatic breast cancer. In the early setting, Herceptin is approvedfor use following standard (adjuvant) chemotherapy.

Herceptin is marketed in the United States by Genentech, in Japanby Chugai and internationally by Roche. Since 1998, Herceptin hasbeen used to treat more than 450,000 HER2-positive breast cancerpatients worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in in-vitrodiagnostics and drugs for cancer and transplantation, and is a marketleader in virology. It is also active in other major therapeuticareas such as autoimmune diseases, inflammatory and metabolicdisorders and diseases of the central nervous system. In 2007 salesby the Pharmaceuticals Division totalled 36.8 billion Swiss francs,and the Diagnostics Division posted sales of 9.3 billion francs.Roche has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai, and invested over 8 billion Swiss francs in R&D in 2007.Worldwide, the Group employs about 79,000 people. Additionalinformation is available on the Internet at http://www.roche.com.

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(1) Sachelarie I, et al. Primary systemic therapy of breastcancer. The Oncologist. 2006;11:574-589

(2) Gianni L, et al., Neoadjuvant trastuzumab in locally advancedbreast cancer (NOAH):antitumor and safety analysis. Abstract # 532.American Society of Clinical Oncology Annual Meeting 2007

(3) Rastogi et al. Preoperative chemotherapy: updates of NationalSurgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. JClin Oncol. 2008 Feb 10;26(5):778-85

(4) Kaufmann, von Minckwitz. Preoperative (neoadjuvant) systemictreatment of breast cancer. Breast. 2005 Dec;14(6):576-81

(5) Harries M, Smith I. The development and clinical use oftrastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002

(6) World Health Organization,http://www.who.int/cancer/detection/breastcancer/en/

(7) Cancer Incidence, Mortality and Prevalence Worldwide. IARCCancerBase No.5, Version 2.0. IARCPress, Lyon, 2004

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information please contact: Corinne Fründt, F. Hoffmann-La Roche Ltd, Mobile: +41-(0)79-5937216, corinne.fruendt@roche.com. Patricia Dessert, Ketchum, Mobile : +44-(0)7980-313-147, patricia.dessert@ketchum.com

Roche Pharmaceuticals

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Herceptin(R) Helps Eradicate HER2-Positive Breast Tumours When Given Before Surgery

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