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EFFECTIVENESS OF HERCEPTIN(R) TO TREAT ADVANCED BREAST CANCER DEMONSTRATED IN PRESENTATIONS AT PROMINENT CANCER CONFERENCE New Findings Report Significant Increased Overall Survival London, May 17 -- New information on the effectiveness of Herceptin as an anti-breast cancer agent was reported in three separate presentations at the annual scientific session of the American Society of Clinical Oncology (ASCO). Leading cancer specialists attending the conference this week in Atlanta, Georgia learned about Herceptin's positive therapeutic effect when used as a treatment for advanced -- or metastatic -- breast cancer. The presentations evaluated Herceptin's impact on overall survival, its ability to improve patients' quality of life, and its effectiveness when administered in combination with the commonly used chemotherapeutic breast cancer agent, Taxol. Hundreds of researchers and patients from throughout Europe, the United States and Canada participated in the studies. The new findings not only provide important information on the clinical effectiveness of Herceptin, but present insights into the influence of a specialised receptor found on the surface of breast cancer cells. The receptor, called HER2, is overproduced -- or overexpressed -- in some women with breast cancer. An increased amount of HER2 is a marker for a very aggressive form of breast cancer. Researchers believe approximately 30 percent of all breast cancers overexpress HER2. Herceptin works by blocking the HER2 receptor, making it a potentially powerful and targeted tool in the fight against breast cancer. Overall Survival Improves When Herceptin Is Added to Chemotherapy In a randomised, controlled study of 469 women with metastatic breast cancer, the addition of Herceptin to standard chemotherapy regimens significantly improved survival when compared to women who received chemotherapy alone. All women in the trial had tested positive for HER2 overexpression. Data presented showed that the combination of Herceptin and chemotherapy decreased the death rate by 23 percent compared with chemotherapy alone. After a median follow-up period of 29 months, women treated with a combination of either Herceptin plus doxorubicin (or epirubicin) and cyclophosphamide (AC therapy), or Herceptin plus paclitaxel (Taxol) survived on average more than five months longer than those treated with the chemotherapy drugs alone (25.4 months vs. 20.3 months). These new results expand on the earlier findings and demonstrate again how Herceptin can treat advanced breast cancer and help patients live longer. George W. Sledge, MD, Indiana University Medical Center told delegates, ''Now with these results, I think Herceptin joins a very short list of agents that are proven in a randomised trial to improve overall survival for metastatic breast cancer ...this changes everything. HER2 testing and Herceptin therapy should be considered part of the routine standard of care in metastatic breast cancer.'' These results were particularly impressive because the study protocol allowed patients whose disease progressed to receive Herceptin therapy and/or other anti-cancer treatments. Thus many patients who were initially randomised to chemotherapy treatment alone subsequently received Herceptin therapy, which could have reduced the apparent treatment benefit in the group who received Herceptin from the start. The results show that the improved response rates are accompanied by survival benefits, and suggest that early treatment with Herceptin therapy is important to achieve an optimal response. In addition Herceptin was very well tolerated. There were several cases of severe cardiac dysfunction, which were more common in the Herceptin plus AC group. Physicians recognise cardiac dysfunction as a side effect with AC therapy. The study was conducted by the Multinational Herceptin Investigator Group, involving research centres in Munich, Barcelona, Montreal, New York, Los Angeles, Chicago, Seattle and South San Francisco. Quality-of-Life Increases With Herceptin Use While conventional treatments for breast cancer can be successful in halting tumour growth, they often indiscriminately kill healthy as well as malignant cells, causing side effects such as vomiting, hair loss and the destruction of immune-system cells. These side effects can contribute to a significant decline in patients' overall quality-of-life. Researchers evaluating Herceptin's impact on a range of quality-of-life factors uncovered encouraging results among 222 women at 56 centres in seven countries with advanced breast cancer who participated in their unblinded, single-agent study. Study participants, who had all undergone one or two previous chemotherapy regimes, completed a standard quality-of-life survey at the study's start and again at 12-week intervals. The women reported their feelings and abilities in five categories: global quality-of-life, physical, social and role functioning, and fatigue. An analysis of the data presented at ASCO found that the administration of single-agent Herceptin significantly improved global quality-of-life and social functioning measurements. ''Data reported at this year's ASCO conference are exceptional and truly encouraging for all involved in the care of women with advanced breast cancer,'' said Prof. Erich Platzer, Therapeutic Area Director, Oncology, Roche Pharmaceuticals. ''The more we study Herceptin -- whether alone or in combination with other drugs -- the more we learn about its targeted and powerful ability to thwart tumour growth while sparing patients from unacceptable side effects. Clearly, a greater understanding of Herceptin and the HER2 pathway may help the oncology community find improved treatment regimes for people with the most aggressive, advanced cancers.'' HER2+ Patients See Significant Benefit With Combination Of Weekly Taxol & Herceptin A study of 63 metastatic breast cancer patients presented at the ASCO conference suggests that the combination of weekly Taxol and Herceptin has a high overall response rate. When researchers evaluated the results of patients who completed the Phase II trial, 52 percent demonstrated a response to the therapy. Response rates among HER2 positive patients were very encouraging, with 62 percent responding to therapy. Women participating in the study had undergone one to three previous chemotherapy regimes, and 21 percent were refractory -- or unresponsive -- to anthracycline, the most commonly prescribed chemotherapeutic agent among study participants. Peripheral neuropathy, or the reduction of sensation in the hands and feet, was the most commonly seen major side effect. The study's leaders include breast cancer experts at Memorial Sloan- Kettering Cancer Center in New York and the M.D. Anderson Cancer Center in Houston, Texas. Results of this study indicate that Herceptin is well tolerated and seems to be very effective when used in combination with weekly Taxol. Roche Pharmaceuticals Herceptin was discovered and developed by Genentech, a leading U.S. biotechnology company in which Roche holds a 67 percent stake. In July 1998, Genentech granted Roche exclusive marketing rights for Herceptin outside the United States. Roche and Genentech will also work together in a joint global development program for other solid tumours such as non-small cell lung and colorectal cancers. Roche, headquartered in Basel, Switzerland, is a world-wide leader in research-based healthcare with principal business in pharmaceuticals, diagnostics, vitamins, and fragrances and flavours. Roche discovers, develops and markets prescription drugs in key therapeutic areas such as diseases of the nervous system, virology, infectious diseases, oncology, cardiovascular diseases, inflammatory and autoimmune diseases, dermatology, metabolic disorders and respiratory diseases. CONTACT: Robin Gallon +44-1-235-554627; or on-site at ASCO: Kim Callahan +1-917-856-9580, both for Roche Pharmaceuticals