Media Release

Basel, 02 June 2012

Roche study showed that adding Avastin to chemotherapy cut the risk of the disease getting worse in difficult-to-treat recurrent ovarian cancer by half

First phase III study of Avastin plus chemotherapy in platinum-resistant ovarian cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from AURELIA, a phase III study that evaluated treatment with Avastin (bevacizumab) in combination with standard chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) in women with ovarian cancer whose disease had worsened due to resistance to platinum-containing chemotherapy. The risk of progression was reduced by 52 percent in women who received Avastin plus chemotherapy compared with those who received chemotherapy alone (HR = 0.48, p<0.001). The study met its primary endpoint of a significant improvement in progression free survival (PFS, the time a woman lives without the disease getting worse). Adverse events in AURELIA were consistent with those seen in previous pivotal trials of Avastin across tumour types.

These results were featured in a press briefing on Friday, June 1 at the 48th Annual Meeting of the American Society of Clinical Oncology. Full results will be presented in the ASCO Gynaecologic Cancer Oral Abstract session by Professor Eric Pujade-Lauraine, the AURELIA Principal Investigator and Head of the Medical Oncology Dept., Hopitaux Universitaires, Paris Centre, Hôpital Hôtel-Dieu (Abstract LBA5002, Saturday 2 June, 3:30 p.m. CDT).

“Most women with advanced ovarian cancer will experience disease progression after treatment, and almost all of them will at some stage of the disease have cancer that is resistant to platinum-based chemotherapy which severely limits treatment options,” said Hal Barron M.D., Chief Medical Officer and Head Global Product Development. “Adding Avastin to chemotherapy for women with advanced ovarian cancer in this study reduced their risk of cancer progression by half.”

In December 2011 Avastin received European approval for use in the front-line treatment of advanced ovarian cancer, based on the results from GOG 0218 and ICON7. Roche will share the AURELIA data with health authorities and discuss appropriate next steps.

AURELIA Study Results

  • Women with recurrent, platinum-resistant ovarian cancer who received Avastin in combination with chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) had a median progression free survival of 6.7 months compared to 3.4 months in women who received chemotherapy alone.
  • In addition, they had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to women who received chemotherapy alone (30.9 percent versus 12.6 percent, p=0.001).

AURELIA is the fourth phase III study of Avastin in ovarian cancer (following GOG 0218, ICON7 and OCEANS) to show that adding Avastin to chemotherapy significantly increased the time women with this disease lived without their disease getting worse.

About the AURELIA study

AURELIA is a multicentre, randomised, open-label, two-arm phase III study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Women in AURELIA had received no more than two anticancer regimens prior to enrolment in the trial. The trial was designed to evaluate Avastin (10mg/kg every two weeks or 15mg/kg every three weeks) in combination with standard chemotherapy (either weekly paclitaxel or topotecan or pegylated liposomal doxorubicin) compared to standard chemotherapy alone.

The trial was set up in cooperation with the Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and was conducted by the international network of the Gynecologic Cancer Intergroup (GCIG) and the pan-European Network of Gynaecological Oncological Trial Groups (ENGOT). The primary endpoint of the study was progression-free survival. The secondary endpoints of the study included overall survival, objective response rate, Quality of Life, safety and tolerability.

When treating ovarian cancer, the time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-resistant’ disease if their disease worsens between one and six months of completing their platinum-based chemotherapy, and ‘platinum-sensitive’ disease if it worsens more than six months after.

About Ovarian Cancer

Ovarian cancer is the eight most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Annually, an estimated 230,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease1. Surgery to remove as much of the tumour as possible is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease (when the cancer has grown or spread) and they require further treatment.

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumor growth and spread. Studies have shown a correlation between a high concentration of VEGF and ascites development (excess fluid in the abdominal cavity), disease worsening, and a poorer prognosis in women with ovarian cancer. Avastin is designed to specifically target VEGF.

About Avastin: Over 7 Years of Transforming Cancer Care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer and breast cancer. Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today – over one million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

About Avastin: Mode of Action

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) – a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF for continuous tumour control. Avastin’s precise VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

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1) WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008