Friday, Dec 8, 2000
South San Francisco, Calif. -- December 8, 2000 --Genentech, Inc., (NYSE: DNA) today announced that four Phase III randomized clinical trials are currently enrolling or planning to enroll more than 10,000 women at 800 sites worldwide with early stage (adjuvant) breast cancer. Adjuvant therapy is given to women with breast cancer who have had initial treatment, most often surgery, to try to attack any cancer cells that may remain in the body with the goal of preventing relapse.
The purpose of these clinical trials is to determine the safety and efficacy of adding Herceptin® (Trastuzumab) to chemotherapy in the adjuvant setting as a potential treatment option for the 25-30 percent of women with breast cancer who have tumors that are HER2 (human epidermal growth factor receptor2) positive. HER2 positivity is an indicator of more aggressive disease and a poorer prognosis.
"Herceptin has been a major advance in the treatment of women with HER2 positive metastatic breast cancer," said Gwen Fyfe, M.D., Genentech's senior director of Oncology. "When used in combination with chemotherapy as the initial therapy for women with metastatic disease, Herceptin has demonstrated an important survival advantage over chemotherapy alone, an advantage that few therapies have shown in this setting."
"Research has shown that women with HER2 positive breast cancer have a greater likelihood of recurrence and have approximately half the life expectancy of women with HER2 negative breast cancer. For this reason, studying whether Herceptin can be used safely and effectively earlier in the disease for women is clearly warranted," continued Dr. Fyfe.
"Clinical trials are the only way to learn whether Herceptin can benefit women with early stage breast cancer. We urge women with early stage HER2+ disease to discuss participation in a clinical trial with their doctor, and we challenge physicians to discuss proactively these clinical trials with their patients," said Fran Visco, President of the National Breast Cancer Coalition.
Background on the Trials
Genentech is collaborating with three leading cooperative groups: the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Breast Cancer International Research Group (BCIRG), and the North Central Cancer Treatment Group (NCCTG). The NCCTG trial is an InterGroup study open to institutions from the Southwest Oncology Group (SWOG), Eastern Cooperative Oncology Group (ECOG) and the Cancer and Leukemia Group B (CALGB). Additionally, a fourth Phase III trial will be conducted outside the United States, exclusively, by F. Hoffmann-La Roche.
Both the NSABP and NCCTG trials will evaluate the combination of doxorubicin and cyclophosphamide (AC) followed by paclitaxel, with and without Herceptin using different treatment schedules of paclitaxel. The BCIRG trial will evaluate AC followed by doxetaxel with and without Herceptin, and will also evaluate a non-anthracycline based regimen of docetaxel, carboplatinum and Herceptin. The Roche trial, which is scheduled to begin in early 2001, will evaluate Herceptin following any chemotherapy regimen for the adjuvant treatment of high risk breast cancer.
The trials will include close monitoring of cardiac safety for all participants and include interim safety analyses after a pre-determined number of patients have been treated prior to concluding the efficacy part of the trial. The Phase III trials are being supported in part by Genentech and our collaborators at the National Cancer Institute. In addition, Aventis is also supporting the BCIRG trial.
Women with breast cancer or caregivers interested in learning more about the Herceptin adjuvant trials should speak to their physicians and/or call the National Cancer Institute's (NCI) Cancer Information Service (CIS) at 1-800-4-CANCER or visit the NCI's clinical trials website at cancertrials.nci.nih.gov. Additionally, women interested in the BCIRG trial can call 514-748-3940 or email [email protected]
Herceptin received 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 treatment of patients both as first line therapy in combination with paclitaxel and as a single agent in second and third line therapy. Metastatic disease is characterized by having tumors that have spread beyond the initial breast tumor, usually to the bone and/or any major organ system.
Approximately 1.6 million women have been diagnosed with breast cancer in the United States. According to the American Cancer Society, approximately 180,000 new cases are diagnosed in any given year. In 25 to 30 percent of women with breast cancer, there is a genetic abnormality in the HER2 gene that produces an increased amount of the growth factor receptor protein on the tumor cell surface. This HER2 protein overexpression is associated with more aggressive disease. Routine testing of the tumors from women with breast cancer is critical for identification of patients with HER2 driven disease that are eligible for a clinical trial or could benefit from Herceptin in the metastatic setting.
Herceptin was generally well tolerated by the 958 women treated in clinical trials. Overall, the most common adverse events have been chills and fever in approximately 40 percent of patients, primarily with the first infusion. An increased risk of cardiac dysfunction has been observed in women receiving Herceptin and anthracyclines (28%) compared to those receiving anthracyclines alone (7%), as well as those receiving Herceptin and paclitaxel (11%) compared to paclitaxel alone (1%) in the pivotal trials. This side effect can be potentially severe or life-threatening, but in most cases can be managed with medication or through discontinuation of Herceptin. Additionally, in the post-marketing setting, rare serious and fatal infusion-related events have occurred. Most patients who experienced the more serious and fatal infusion-related events had pre-existing pulmonary compromise and advanced malignancy.
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently marketed biotechnology products stem from Genentech science, nine of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange and the Pacific Exchange under the symbol DNA.
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