Phase III study showed Avastin-based regimen helped women with advanced ovarian cancer

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced results from a Phase III study of Avastin (bevacizumab) that showed women with previously untreated advanced ovarian cancer who received Avastin in combination with chemotherapy, followed by the continuation of Avastin alone, had a 39 percent improvement in the likelihood of living longer without the disease worsening compared to chemotherapy alone. An assessment of safety noted adverse events consistent with those observed in pivotal trials of Avastin. The study (known as GOG 0218), was conducted by a network of researchers led by the Gynecologic Oncology Group (GOG).

These results were featured in a press briefing today at the 46th Annual Meeting of the American Society of Clinical Oncology. Full results will be presented at the ASCO plenary session by Dr. Robert Burger, M.D., the GOG 0218 Study Chair and Director of the Women's Cancer Center at Fox Chase Cancer Center (Abstract LBA001, Sunday 6 June, 1:45 p.m. CDT).

"Ovarian cancer is a difficult-to-treat disease with high morbidity and mortality, and there have been limited advances in treatment in the past decade," said Dr. Burger. "These results may represent an important step forward for women who need more options."

GOG 0218 demonstrated that women with advanced ovarian cancer who received front-line (first-line following surgery) Avastin in combination with chemotherapy (paclitaxel and carboplatin), and continued use of Avastin alone for a total duration of up to 15 months, had a median PFS of 14.1 months compared to 10.3 months in women who received chemotherapy alone (hazard ratio = 0.72, p=<0.0001, a 28 percent reduction in the risk of cancer progression or death, which corresponds to a 39% improvement in the likelihood of living longer without the disease worsening). The study also investigated Avastin in combination with chemotherapy but without the continuation of Avastin alone. Women who received this shorter duration of Avastin did not have a statistically significant increase in PFS compared with chemotherapy alone.

"We are encouraged by these results as there have been few improvements in outcomes for women with this disease in the past decade. Avastin in combination with chemotherapy, followed by the continued use of Avastin, helped women with advanced ovarian cancer live longer without their disease worsening," said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche. "We will discuss these data and next steps with U.S. and global regulatory authorities."

Additional efficacy analysis
The GOG 0218 study protocol allowed for different ways to determine if a patient's disease had progressed (worsened). Disease progression could be measured based exclusively on levels of a protein (CA-125) in the blood, or through the use of CA-125 levels and evidence of progression by a radiograph/scan. (CA-125 is measured by a blood test and is sometimes used to demonstrate a response to chemotherapy or to diagnose a recurrence or progression of ovarian cancer.)

An analysis of efficacy was conducted for regulatory purposes that only included disease progressions determined by radiographs/scans (excluding progressions based on CA-125 alone). In this analysis, women who continued Avastin, following Avastin in combination with chemotherapy, had a median PFS of 18.0 months compared to 12.0 months in women who received chemotherapy alone, increasing the likelihood of them living longer without the disease worsening by 54 percent (based on a hazard ratio = 0.65, p=<0.0001, which corresponds to a 35 percent reduction in the risk of cancer progression or death).

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 who already had surgery to remove as much of the tumor as possible. Patients were randomised to receive one of the following:

  • Arm 1: Placebo in combination with commonly-used chemotherapy followed by placebo for a total treatment duration of up to 15 months
  • Arm 2: Avastin in combination with commonly-used chemotherapy followed by placebo for a total treatment duration of up to 15 months
  • Arm 3: Avastin in combination with commonly-used chemotherapy followed by the continuation of Avastin alone, as maintenance therapy, for a total treatment duration of up to 15 months

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 Gynecologic Oncology Group (GOG). The primary endpoint of the study is PFS as assessed by trial investigators. Secondary endpoints of the study include overall survival, PFS by independent review, safety, quality of life measures and analysis of patient tumor and blood samples.

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 the GOG's 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).

About ovarian cancer
Ovarian cancer is the sixth most commonly diagnosed cancer in women and the eighth 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. Currently, treatment options for women with this disease are limited to surgery, and chemotherapy. 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 a poorer prognosis in women with ovarian cancer. Avastin is designed to specifically target VEGF.

About Avastin: Over 5 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 the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and 23 other countries for the treatment of patients with advanced brain cancer (glioblastoma). 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 three quarters of a 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 tumor types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

About Avastin: Mode of Action
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis - a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.

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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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: www.roche.com.

Garcia M et al. Cancer Facts & Figures 2007. Atlanta, American Cancer Society, 2007.

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