New Study Shows Promising Results for Herceptin / Safety and Efficacy Demonstrated in Women With Advanced HER2- Positive Breast Cancer

BASEL, Switzerland (PROTEXT) - Women with advanced(metastatic) breast cancer who were treated with Herceptin(R)(trastuzumab) demonstrated long-lasting, significant response totherapy with almost none of the side effects commonly seen withconventional chemotherapeutic agents, according to a study of 222women with HER2-positive breast cancer published in the SeptemberJournal of Clinical Oncology. "These HER2-positive breast cancer patients had a very poorprognosis and despite aggressive treatment, their cancers hadprogressed," said Dr. Melody Cobleigh, Rush-Presbyterian-St.Luke's Medical Center, Chicago, Illinois, USA and leadinvestigator of the study. "Therefore, the response rate and theduration of response seen in this study are significant. Womentreated with Herceptin also showed an initial stabilisation intheir quality of life. Cancer patients experience a decrease intheir quality of life brought on not only by the cancer but alsoby conventional chemotherapy, and this stabilisation is veryimportant for the emotional well-being of these patients." The study examined 222 women with HER2-positive tumours whoreceived Herceptin monotherapy for cancer that had progressedafter at least one prior course of chemotherapy. According to anindependent response evaluation committee comprised ofradiologists and oncologists, 15 percent of patients responded toHerceptin treatment. Eight women (4 percent) who receivedHerceptin had a complete response, defined as no evidence of thecancer in their body, and 26 women (11 percent) had a partialresponse, defined as a decrease in tumour size of at least 50percent. At six months, 22 percent of patients were free ofdisease progression. Among the 34 responders, average time-to-treatment failure (TTF), defined as the time from initiation ofthe study to disease progression, was 11 months. These samepatients had an average TTF of only 5.1 months with their priorchemotherapy regimen. Herceptin targets the HER2 receptor (human epidermal growthfactor receptor 2), a protein found in excessive amounts on thesurface of some breast cancer cells. Approximately 30 percent ofwomen with breast cancer overexpress HER2, and suchoverexpression of HER2 is associated with a more aggressive formof the disease. However, this study found that higher levels ofHER2 expression correlated with a better response to Herceptin. Because Herceptin targets a specific cellular receptor and notall rapidly dividing cells, as do most chemotherapies, Herceptintreatment produces almost none of the commonly observed sideeffects associated with chemotherapy such as hair loss, nausea,vomiting, and immune system toxicity. "In the majority of cases, patients who have taken this drughave also received chemotherapy, and as far as they areconcerned, it's like comparing day and night," said Dr. MartinePiccart, Assistant Professor in the Department of InternalMedicine and Head of the Chemotherapy Department, Jules BordetInstitute, Brussels, Belgium. "With Herceptin, they have avirtually normal life. They are not tired. They are not ill, andconsequently the majority, if not all, patients much prefer thistreatment to chemotherapy." The most common side effects in this study were mild-to-moderate and included fever, chills, pain, and shortness ofbreath. These side effects usually did not recur after the firstinfusion. Twenty-nine of the 222 patients suffered severe sideeffects, including ten women (less than 5 percent) who hadsymptoms of cardiac dysfunction. All ten had risk factors forcardiac complications, including anthracycline treatment or pre-existing cardiac disease, and most of the patients improved afterstandard medical treatment. Overall, only one percent of patientswere withdrawn from the study due to side effects. Roche Pharmaceuticals Herceptin was discovered and developed by Genentech, Inc., aleading U.S. biotechnology company in which Roche owns a majorityshare. In July 1998, Genentech granted Roche exclusive marketingrights for Herceptin outside the United States. Roche andGenentech will also work together in a joint global developmentprogram for other solid tumours, such as non-small cell lung andcolorectal cancers. Roche, headquartered in Basel, Switzerland, is a world-wideleader in research-based healthcare with principal business inpharmaceuticals, diagnostics, vitamins, and fragrances andflavours. Roche discovers, develops, and markets prescriptiondrugs in key therapeutic areas such as diseases of the nervoussystem, virology, infectious diseases, oncology, cardiovasculardiseases, inflammatory and autoimmune diseases, dermatology,metabolic disorders, and respiratory diseases. ots Original TextService: Roche Pharmaceuticals Internet:http://www.newsaktuell.de Contact: Kim Callahan, 212-453-2425,or callahak@fleishman.com, or Melinda Winter, 212-453-2456,winterm@fleishman.com, both of Fleishman Hillard, for Roche

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