Thursday, Jul 1, 2010

Second Phase III Study Showed Avastin-Containing Regimen Helped Women with Ovarian Cancer Live Longer Without their Disease Getting Worse

Study of Avastin in combination with standard chemotherapy, followed by continued use of Avastin, met primary endpoint of improving progression-free survival in women with ovarian cancer

South San Francisco, Calif. -- July 1, 2010 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a second large, Phase III, international study showed that the combination of Avastin® (bevacizumab) and chemotherapy, followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone. Adverse events were consistent with those observed in pivotal trials of Avastin across tumor types for approved indications. Data from the study, known as ICON7, will be submitted for presentation at an upcoming medical meeting.

"With few advances in ovarian cancer and a need to improve outcomes for women with this disease, it is encouraging that a second Phase III study showed that Avastin in combination with chemotherapy followed by the continued use of Avastin alone helped women live longer without their disease getting worse," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "ICON7 is part of our continued commitment to understand the full potential of Avastin in ovarian cancer, which includes several Phase III studies in combination with other agents and in various stages of the disease."

The ICON7 study is sponsored by the Medical Research Council (MRC) in the United Kingdom (U.K.), led by the MRC Clinical Trials Unit and conducted through an international network of researchers in the Gynecologic Cancer InterGroup (GCIG). In the study, 1,528 women with newly diagnosed ovarian cancer who already had surgery were randomized to receive one of the following:

  • Arm 1: Chemotherapy (carboplatin and paclitaxel) for 6 cycles
  • Arm 2: Avastin (7.5mg/kg every three weeks) in combination with chemotherapy (carboplatin and paclitaxel) for 6 cycles followed by Avastin alone (for a total of 18 cycles, up to 12 months)

Another Phase III study of Avastin (known as GOG 0218) in women with previously untreated advanced ovarian cancer presented in June at the Annual Meeting of the American Society of Clinical Oncology (ASCO) also met its primary endpoint of PFS. The GOG 0218 study used an Avastin dose of 15mg/kg (every three weeks) in combination with carboplatin and paclitaxel, followed by the continued use of Avastin alone, for a total duration of up to 15 months. In ICON7, the majority of patients had advanced stage ovarian cancer, however, the trial also included patients with earlier stage disease. The ICON7 study used an Avastin dose of 7.5mg/kg (every three weeks) in combination with the same chemotherapy regimen, followed by the continued use of Avastin alone, for a total duration of up to 12 months.

About the ICON7 Study
ICON7 is an international, multicenter, randomized, open-label, Phase III study in 1,528 women with previously untreated epithelial ovarian, primary peritoneal or fallopian tube carcinoma. The trial evaluates Avastin plus standard of care chemotherapy (carboplatin and paclitaxel) followed by the continued use of Avastin alone, compared to chemotherapy alone.

The primary endpoint of the study is PFS as assessed by trial investigators. Secondary endpoints of the study include overall survival, response rate, duration of response, quality of life and safety.

About Ovarian Cancer
According to the American Cancer Society, ovarian cancer is the fifth leading cause of cancer death among American women. In 2010, an estimated 21,800 women will be diagnosed with ovarian cancer and approximately 14,000 will die 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 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.

Boxed WARNINGS and Additional Important Safety Information
People treated with Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine or large intestine. In clinical trials, this side effect occurred in more people who received Avastin than in the comparison group (0.3 percent to 2.4 percent). In some cases, GI perforation resulted in fatality.

Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of having surgery and wound healing problems following surgery has not been determined.

Severe bleeding: Treatment with Avastin can result in serious bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin.

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine, which led to kidney problems, was seen in less than 1 percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in 5 percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2 percent of people.

Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.

Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.

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 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 Medical Research Council
For almost 100 years the Medical Research Council has improved the health of people in the U.K. and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognized research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including the first antibiotic penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC-funded scientists tackle research into the major health challenges of the 21st century. http://www.mrc.ac.uk

About GCIG
The Gynecologic Cancer InterGroup is an organization of representatives from international and national research groups performing clinical trials in gynecological cancer. It aims to promote international collaboration on clinical research by performing high quality clinical trials.

GCIG groups who participated in ICON7 included:

  • AGO-OVAR (Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany)
  • ANZGOG (Australia and New Zealand Gynecological Oncology Group)
  • GINECO (Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens)
  • GEICO (Grupo Espanol de Investigacion en Cancer de Ovario)
  • MRC/NCRI (Medical Research Council/National Cancer Research Institute)
  • NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
  • NSGO (Nordic Society of Gynecologic Oncology)

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