Genentech Announces Positive Results of Avastin Phase III Study in Women with Advanced Ovarian Cancer

Genentech Announces Positive Results of Avastin Phase III Study in Women with Advanced Ovarian Cancer

-- First Phase III study of an anti-angiogenic therapy in advanced ovarian cancer to meet primary endpoint  --

South San Francisco, Calif. --  February 24, 2010 --  Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that a Phase III study showed the combination of Avastin® (bevacizumab) and chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone. A preliminary assessment of safety noted adverse events previously observed in pivotal trials of Avastin. Data from the study will be submitted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.

In the three-arm study, known as Gynecologic Oncology Group (GOG) 0218, women with newly diagnosed advanced ovarian cancer who already had surgery to remove as much of the tumor as possible were randomized to receive one of the following:

• Arm 1: Placebo in combination with carboplatin and paclitaxel chemotherapy followed by placebo alone, for a total of up to 15 months of therapy
• Arm 2: Avastin in combination with carboplatin and paclitaxel chemotherapy followed by placebo alone, for a total of up to 15 months of therapy
• Arm 3: Avastin in combination with carboplatin and paclitaxel chemotherapy followed by the maintenance use of Avastin alone, for a total of up to 15 months of therapy.

The study showed that women who continued maintenance use of Avastin alone, after receiving Avastin in combination with chemotherapy (Arm 3), lived longer without the disease worsening compared to those who received chemotherapy alone. Women who received Avastin in combination with chemotherapy, but did not continue maintenance use of Avastin alone (Arm 2), did not live longer without the disease worsening compared to chemotherapy alone.

"Additional medicines are urgently needed for women with newly diagnosed advanced ovarian cancer, as most women's cancer will worsen after their initial treatment," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.

"We are encouraged by the positive findings of this study, which highlight the importance of continuing maintenance Avastin after combining Avastin with chemotherapy in this setting. We will discuss these results with the U.S. Food and Drug Administration."

"This is good news for women with ovarian, primary peritoneal or fallopian tube cancers," said GOG 0218 study chair Robert Burger, M.D., Fox-Chase Cancer Center in Philadelphia. "This study showed that after initial surgery, the combination of Avastin and chemotherapy followed by extended treatment with Avastin improves progression-free survival in women with newly diagnosed advanced tumors."

The trial is sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement between the NCI and Genentech, and is being conducted by a network of researchers led by the GOG.

Avastin is being studied worldwide in more than 450 clinical trials for multiple types of cancer, including approximately 25 ongoing clinical trials in the United States for women with various stages of ovarian cancer.

About Ovarian Cancer
According to the American Cancer Society, ovarian cancer is the fifth leading cause of cancer death among American women. In 2009 an estimated 21,500 women were diagnosed with ovarian cancer and approximately 14,500 died from the disease in the U.S. The disease causes more deaths than any other gynecologic cancer, and the American Cancer Society estimates that nearly 70 percent of women with advanced disease will die from it within five years.

Ovarian cancer is associated with high levels of vascular endothelial growth factor (VEGF), a protein associated with tumor growth and spread. Studies have shown a correlation between a high level of VEGF and a poorer prognosis in women with ovarian cancer. Currently, treatment options for women with this disease are limited to surgery and chemotherapy.

About the GOG 0218 Study
GOG 0218 is an international, multicenter, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma. The study evaluates Avastin (5 cycles) in combination with carboplatin and paclitaxel chemotherapy (6 cycles) compared to carboplatin and paclitaxel chemotherapy alone (6 cycles). The trial is also designed to assess the maintenance use of Avastin alone following the initial combined regimen of Avastin and chemotherapy (for a total of up to 15 months of therapy), compared to carboplatin and paclitaxel chemotherapy alone (6 cycles).

The primary endpoint of the study is PFS as assessed by trial investigators. Secondary and exploratory endpoints of the study include overall survival, PFS by independent review, objective response rate, safety, quality of life measures and analysis of patient tumor and blood samples.

Detailed safety assessments are ongoing. A preliminary assessment of safety performed by the GOG identified Avastin-related serious adverse events noted in previous pivotal studies, including fatal neutropenic infection and gastrointestinal perforation. The full study results, including safety information, will be presented at a future medical meeting.

About Avastin
Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called VEGF. VEGF plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

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, California. For additional information about the company, please visit http://www.gene.com.

About The Gynecologic Oncology Group (GOG)
The Gynecologic Oncology Group is a non-profit organization of more than 300 member institutions with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of Gynecologic malignancies. The Group is committed to maintaining the highest standards in the clinical trial development, execution, analysis and distribution of results. Continuous evaluation of our processes is utilized in order to constantly improve the quality of patient care.

GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health (NIH).