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New Genentech (RHHBY) Breast Cancer Drug Shows Late Stage Trial Success


3/30/2012 6:39:17 AM

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced topline results of EMILIA, the first randomized Phase III study of trastuzumab emtansine (T-DM1). The study enrolled people with HER2-positive metastatic breast cancer (mBC) who had previously received treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, or PFS) compared to those who received lapatinib plus Xeloda® (capecitabine). Final results for overall survival (OS), a co-primary efficacy endpoint of EMILIA, are not yet mature. The safety profile of trastuzumab emtansine was consistent with that seen in previous studies. These data will be submitted for presentation at an upcoming medical meeting.

Trastuzumab emtansine is an investigational medicine known as an antibody-drug conjugate (ADC). It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. Trastuzumab emtansine reinforces Roche’s personalized healthcare approach of developing targeted medicines to fight cancer.

“Trastuzumab emtansine represents a new approach for the treatment of people with HER2-positive breast cancer that comes from our decades of research on the HER pathway,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are excited about the EMILIA results because trastuzumab emtansine is our first antibody-drug conjugate and it may help people who still need more treatment options for this aggressive disease. We will work to submit these data to regulatory authorities as quickly as possible.”

Based on these findings, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) this year for HER2-positive mBC. In addition, Roche plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) this year for the same indication.

About the EMILIA Study

EMILIA (TDM4370g/BO21977) is an international, Phase III, randomized, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 991 people with HER2-positive mBC whose disease progressed after initial treatment with Herceptin and a taxane chemotherapy.

Participants in the trastuzumab emtansine arm received:

• Trastuzumab emtansine 3.6 mg/kg every three weeks

Participants in the lapatinib and Xeloda arm received:

• Lapatinib 1250 mg daily

• Xeloda 2000 mg/m2, days 1 – 14, every three weeks

The co-primary efficacy endpoints of the study are PFS (as assessed by an independent review committee) and OS. Other study endpoints include safety profile, one-year and two-year survival rates, PFS as assessed by investigator, overall response rate, duration of response and quality of life.

About Trastuzumab Emtansine

Trastuzumab emtansine is an ADC being studied in HER2-positive cancers. Trastuzumab emtansine is designed to inhibit HER2 signaling and deliver the chemotherapy agent DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to the HER2-positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once trastuzumab emtansine is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.

In addition to EMILIA, there are two ongoing Phase III studies of trastuzumab emtansine:

• MARIANNE is comparing three different regimens (trastuzumab emtansine alone, trastuzumab emtansine plus pertuzumab, and Herceptin plus a taxane chemotherapy) in people with HER2-positive mBC who have not been previously treated for their metastatic disease.

• TH3RESA is comparing trastuzumab emtansine to physician's choice of treatment in people with HER2-positive mBC who have already received both Herceptin and lapatinib.

Genentech, a member of the Roche Group, licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.

Building on the results of trastuzumab emtansine studies to date, Roche/Genentech have approximately 30 ADCs in the pipeline.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as “HER2 positivity” and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contact:

Genentech

Media:

Krysta Pellegrino, 650-467-6800

or

Advocacy:

Sonali Padhi, 650-467-0842

or

Investor:

Thomas Kudsk Larsen, 650-467-2016

Karl Mahler, 011 41 61 687 8503


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