FDA Approves Roche’s Avastin Plus Chemotherapy To Treat Women With Platinumresistant Recurrent Ovarian Cancer

Avastin plus chemotherapy reduced the risk of the disease worsening by 62 percent compared to chemotherapy alone in a Phase III study

Basel, 17 November 2014

Avastin plus chemotherapy reduced the risk of the disease worsening by 62 percent compared to chemotherapy alone in a Phase III study

Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Avastin® (bevacizumab) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.¹ The approval was based on results from the Phase III AURELIA study that showed Avastin plus chemotherapy reduced the risk of disease worsening or death (progression-free survival or PFS) by 62 percent compared to women who received chemotherapy alone (median PFS: 6.8 vs. 3.4 months, Hazard Ratio (HR)=0.38; p<0.0001).¹ Adverse events were consistent with those seen in previous trials of Avastin across tumour types for approved indications, but also included high blood pressure and pain, redness or swelling of the hands or feet from the Phase III study.¹

“Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Risk of the disease worsening was reduced by 62 percent for women who received Avastin plus chemotherapy in the study, and a notable treatment effect was observed with paclitaxel, which may be important when choosing treatment.”

The new indication of Avastin is in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens. With this approval, Avastin is approved in the United States to treat six distinct tumour types. Avastin was also approved to treat women with platinum-resistant, recurrent ovarian cancer in the European Union earlier this year.

AURELIA is a company-sponsored, multicentre, randomised, open-label, Phase III study in 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had received no more than two anticancer regimens prior to enrolment in the trial. Participants were randomised to one of six treatment arms (paclitaxel, topotecan or liposomal doxorubicin with or without Avastin). The primary endpoint of the study was investigator-assessed PFS. An analysis of efficacy by chemotherapy type is shown below.

Ovarian cancer causes more deaths than any other gynaecologic cancer.² In 2014, nearly 22,000 women will be diagnosed with ovarian cancer in the United States and more than 14,000 will die from the disease.³ Patients are said to have ‘platinum-resistant’ disease if the disease worsens within six months of completing platinum-based chemotherapy.4 One quarter of those who relapse after initial treatment, more than 4,300 women, will have platinum-resistant cancer, the most difficult-to-treat form of the disease.^3,4

Worldwide, ovarian cancer is the seventh most commonly diagnosed cancer in women, with an estimated 230,000 cases diagnosed around the world every year and there are approximately 150,000 deaths from the disease making it the deadliest of all gynaecological cancers.²

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 U.S. for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and ovarian cancer. In addition, Avastin is approved in the U.S. and over 60 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 1.5 million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 clinical trials is investigating the use of Avastin in over 50 tumour types.

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. Precise VEGF inhibition by Avastin 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.

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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law

References
1. Roche data on file
2. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012 Last accessed October 2014 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
3. American Cancer Society. What are the key statistics about ovarian cancer? Last accessed October 2014 at http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-key-statistics
4. Pujade-Lauraine E et al. J Clin Oncol 2014; 51: 4489

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