Thursday, Dec 4, 2003
San Antonio -- December 4, 2003 --Genentech, Inc. (NYSE: DNA) and Roche (SWX Zurich) today announced updated results from a clinical study evaluating Herceptin® (Trastuzumab) in combination with Taxotere® (docetaxel) as a first-line treatment for HER2-(human epidermal growth factor receptor-2) positive metastatic breast cancer patients. The multi-center, randomized Phase II trial results suggest that adding Herceptin to docetaxel resulted in an increase in median survival of 51 percent, or 9.4 months (27.7 months for patients treated with Herceptin and docetaxel compared to 18.3 months for patients treated with docetaxel alone). Results of this trial were presented at the 26th Annual San Antonio Breast Cancer Symposium.
The overall response rate for patients treated with Herceptin plus docetaxel was significantly increased. Sixty-one percent (56/92) of patients who received Herceptin and docetaxel responded to the combination compared to 36 percent (34/94) of patients treated with docetaxel alone. Median time to disease progression for patients treated with both therapies was 11 months, compared to six months for patients treated with docetaxel alone.
"This study highlights the importance for women diagnosed with metastatic breast cancer to determine their HER2 status and discuss with their physician appropriate first-line therapy with Herceptin," said Gwen Fyfe, M.D., Genentech's vice president, Clinical Oncology/Hematology. "We are encouraged by these results - which are consistent with earlier data with similar combinations - and what they may mean to improving survival for some women battling HER2-positive metastatic breast cancer, often a more aggressive form of the disease."
Researchers reported that patients receiving the Herceptin/chemotherapy combination experienced an increase in febrile neutropenia or neutropenic sepsis over those receiving chemotherapy alone (23 percent vs. 17 percent). Two patients died of septic events in the chemotherapy alone arms. There were two cases of congestive heart failure (CHF) in the Herceptin/chemotherapy arm, only one of which was attributed to Herceptin.
About the Study
The study (abstract # 217) enrolled 188 patients who had evidence of HER2-positive disease by either immunohistochemistry (IHC) or Fluorescence In Situ Hybridization (FISH). Patients were randomized to receive either Herceptin plus docetaxel (n=92) or docetaxel alone (n=94). Two patients did not receive study drug and were excluded from the final analysis. Patients in the Herceptin arm of the study received Herceptin (2mg/kg weekly doses until disease progression following an initial loading dose of 4mg/kg), and docetaxel (100 mg/m2 every 3 weeks for at least 6 cycles). Patients in the docetaxel-only arm received the same dose of docetaxel administered in the Herceptin arm. Patients in the docetaxel arm of the study were given the option to cross over to receive Herceptin, following disease progression.
Herceptin is a targeted therapeutic antibody treatment for women with HER2-positive metastatic breast cancer, an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Special testing is required to identify women who are HER2-positive and candidates for treatment with Herceptin.
Herceptin received U.S. Food and Drug Administration (FDA) approval in September 1998 for use in women with metastatic breast cancer who have tumors that overexpress the HER2 protein. It is indicated for weekly treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech and internationally by F. Hoffmann-LaRoche.
In clinical trials, Herceptin has shown an important survival benefit when used in combination with chemotherapy. In December 2001, Genentech received FDA approval to include data that showed a 24 percent increase in median overall survival for women with HER2-positive metastatic breast cancer treated initially with Herceptin and chemotherapy compared to chemotherapy alone (median 25.1 months compared to 20.3 months).
Herceptin Safety Profile
Herceptin therapy does involve risks. Serious side effects have occurred in patients treated with Herceptin. Herceptin administration can result in the development of ventricular dysfunction and cardiac failure. Severe hypersensitivity reactions (including anaphylaxis), infusion reactions, and pulmonary events have been infrequently reported. Rarely, these were fatal.
Serious reactions were treated by discontinuing Herceptin and administering supportive therapy. In clinical trials, the incidence and severity of cardiac dysfunction was highest in patients receiving Herceptin with anthracycline and cyclophosphamide (AC). Most patients responded to medical therapy, including discontinuation of Herceptin. However, some patients were successfully managed while continuing Herceptin therapy. Patients receiving Herceptin should be monitored for deteriorating cardiac function.
In clinical trials, approximately 40 percent of patients experienced symptoms such as chills and fever during the first infusion. These and other symptoms, including nausea, vomiting, and pain, occurred infrequently with subsequent infusions. In clinical trials, the incidence of moderate to severe neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those receiving chemotherapy alone. There was an increased incidence of anemia leukopenia, diarrhea, and infection when Herceptin was used in combination with chemotherapy.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional information about the company, please visit http://www.gene.com.
Headquartered in Basel, Switzerland, Roche is one of the world?s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people?s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
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