Saturday, Dec 12, 2009

New Phase II Study Showed Trastuzumab-DM1 Shrank Tumors in Women With Highly Advanced HER2-positive Breast Cancer

T-DM1, an Investigational Antibody-Drug Conjugate, Showed Encouraging Results in Women Who Have Received Multiple Prior Medicines

San Antonio -- December 12, 2009 --

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1). As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. Women in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1. No new or unexpected safety signals were observed. Results were presented today at the 32nd Annual San Antonio Breast Cancer Symposium (Abstract #710).

"Despite major advances in HER2-positive breast cancer, the disease may still progress after multiple treatments, to the point where there are no approved HER2-targeted medicines," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "Results from this study are promising for women who need new treatment options, and we will discuss next steps of the T-DM1 development program with the FDA."

"These results are significant because they demonstrate that T-DM1 was effective at shrinking tumors in women whose cancer had progressed following prior treatment with standard therapies for HER2-positive breast cancer," said Ian Krop, M.D., Ph.D., a medical oncologist at Dana-Farber Cancer Institute, and lead investigator on the study.

In this single-arm study, 45 percent of women experienced a clinical benefit (defined as a complete or partial tumor response, or stable disease, maintained for at least six months), as assessed by independent review. Adverse events were similar to those observed in previous clinical trials of T-DM1. The most common severe adverse events included thrombocytopenia (a low level of platelets in the blood, 5.5 percent) and back pain (3.6 percent), and the most common adverse events were fatigue (59.1 percent) and nausea (37.3 percent). No severe (Grade 3 or higher) cardiac-specific side effects were observed. One patient with pre-existing, non-alcoholic fatty liver disease died with hepatic failure.

About the Study (TDM4374g) The Phase II study (known as TDM4374g) is a single-arm, multi-center trial designed to assess T-DM1 as a single agent in 110 women with HER2-positive advanced breast cancer whose disease had progressed after receiving at least two prior HER2-targeted treatments (trastuzumab and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane, and capecitabine. The primary endpoint of the study is objective response rate (a complete or partial tumor shrinkage of at least 30 percent, determined by two tumor assessments at least 28 days apart), as measured by an independent review facility. Secondary endpoints include safety, clinical benefit rate, duration of response and progression-free survival (PFS). Duration of response and PFS data are not yet mature and will be presented at a future meeting.

About T-DM1
T-DM1 is a novel, antibody-drug conjugate (ADC) in development for HER2-positive advanced breast cancer. ADCs are a unique combination of a precise and targeted monoclonal antibody, a stable linker, and a potent cytotoxic. T-DM1 combines two approaches in one medicine: the anti-cancer activity of the trastuzumab antibody, which blocks signals that make the cancer more aggressive and signals the body?s immune system to destroy the cancerous cells, and the targeted delivery of the potent cytotoxic DM1. This year, Genentech and Roche initiated a Phase III study (EMILIA) evaluating T-DM1 in women with advanced HER2-positive breast cancer whose disease has progressed after receiving initial treatment.

Genentech licenses technology for T-DM1 under an agreement with ImmunoGen, Inc. Genentech has a significant development program of ADCs with various targets and in different stages of research and development.

About Advanced HER2-Positive Breast Cancer
According to the American Cancer Society, breast cancer is the second leading cause of cancer death in the United States. Women diagnosed with advanced (metastatic) disease have a poor prognosis and only 27 percent survive five years.

Approximately 15 to 30 percent of breast cancers are HER2-positive. When HER2-positive breast cancer is advanced, the disease has spread to other parts of the body, most commonly to the lungs, bones, liver and brain. At this stage of the disease, the current goals of existing treatments include symptom relief, tumor shrinkage, improved quality of life and increasing the amount of time women with advanced breast cancer live without the cancer worsening. There are no treatment guidelines or FDA-approved treatment options for women with advanced HER2-positive breast cancer if the disease progresses following treatment with trastuzumab and lapatinib.

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 wholly owned member of the Roche Group, has headquarters in South San Francisco, Calif. For additional information about the company, please visit