From rxpgnews.com

Breast
Herceptin Plus Chemotherapy Improves Disease-Free Survival
By Genentech, South San Francisco, Calif.
Apr 26, 2005, 18:41

Genentech, Inc. (NYSE: DNA) today announced that two Phase III trials of Herceptin were stopped early after a preliminary joint interim analysis demonstrated an improvement in the primary endpoint of disease-free survival and in the secondary endpoint of overall survival. The trials compared Herceptin plus chemotherapy to chemotherapy alone as adjuvant therapy following initial treatment with surgery for women with early-stage (or cancer that has not spread beyond the breast and associated lymph nodes) human epidermal growth factor receptor 2 (HER2) positive breast cancer.

The two studies were sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), who conducted this prospectively-designed joint interim analysis following consultation with the FDA. According to the NCI, the cooperative groups will present results from these studies at the American Society of Clinical Oncology (ASCO) annual meeting, May 13�17, 2005.

"The data from these very important Phase III trials suggest for the first time that a therapy that targets women whose tumors have a specific genetic mutation has the potential to reduce the recurrence of disease in early-stage breast cancer patients," said Susan Desmond-Hellmann, M.D., M.P.H., Genentech's president of Product Development. "While further follow-up is necessary, the results of this joint interim analysis suggest that adjuvant therapy with Herceptin plus chemotherapy for women with early-stage HER2-positive breast cancer may increase the chance of long-term survival."

"Conducting this type of joint analysis, which enabled the groups to obtain these important results more than two years earlier than expected is unprecedented and we would like to thank the NSABP, NCCTG, the NCI and the FDA for their extraordinary efforts in combining these studies. We would also like to thank the women who participated in this study for their tremendous courage in making these results possible. Based on the strength of the results, we will work with the cooperative groups to prepare these data for discussion with the FDA about a filing for Herceptin in the adjuvant setting based on this interim analysis," continued Dr. Hellmann.

The NCCTG study enrolled its first patient in June 2000 and has enrolled 3,406 patients to date; the NSABP study began enrollment in March 2000 and has enrolled 2,085 patients to date. The interim analysis was based on information from 3,300 patients. These studies will stop enrolling new patients and the cooperative groups will continue to monitor patients for longer-term data. Each of the studies was a randomized, controlled trial that evaluated the combination of anthracycline and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin using different treatment schedules of paclitaxel in women with HER2-positive breast cancer.

Adverse events in these studies were consistent with those seen in previous Herceptin clinical trials. Each of these studies has an independent, external Data Monitoring Committee (DMC) that reviewed data from the studies, including cardiac safety data. The DMCs monitored safety data on a regular basis and there were three to four percent more cases of serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the heart muscle) in patients receiving the combination of Herceptin plus chemotherapy. Patients in these studies will continue to be followed for any additional side effects.

Based on the positive results from four recent Phase III trial analyses in the past five weeks, three of which occurred earlier than anticipated, Genentech will continue to evaluate its short- and long-term product demand and to assess its manufacturing plans and capacity to meet expected demand. The company expects to provide further information on manufacturing at the time of Q2 earnings results.

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