Media Release

Basel, 27 February 2015

Roche’s Avastin plus chemotherapy receives positive recommendation from CHMP for EU approval in advanced cervical cancer

Combination of Avastin and chemotherapy would be the first new treatment in advanced cervical cancer to extend life in nearly a decade

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the use of Avastin® (bevacizumab) in combination with standard chemotherapy (paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy) for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix.1 Cervical cancer is most commonly diagnosed in younger women, those between the ages of 35 and 44, and every year over 30,000 women in the EU are diagnosed with the disease.2,3

“Treatment options in Europe for women whose cervical cancer has recurred, persisted or spread are currently limited to chemotherapy,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “This CHMP positive opinion for Avastin brings us one step closer to providing women with a much needed, new treatment option that can help them live longer compared to chemotherapy alone.”

The EU filing was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26 percent reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone (median overall survival: 16.8 months vs. 12.9 months; Hazard Ratio (HR)=0.74, p=0.0132).1

In August 2014 in the U.S., and in December 2014 in Switzerland, Avastin was approved in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix, based on the results of the GOG-0240 study.

About the GOG-0240 study1

GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG) that assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer. Study data from 452 women showed:

  • The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death, representing a median gain in survival of 3.9 months, compared with those who received chemotherapy alone (median overall survival: 16.8 months vs. 12.9 months; (HR)=0.74, p=0.0132).1
  • The study showed that women who received Avastin plus chemotherapy had a significantly higher rate of tumour shrinkage (objective response rate, ORR) compared with those who received chemotherapy alone (45 percent [95% CI: 0.39%-0.52%] vs. 34 percent [95% CI 0.28%-0.40%]).1
  • Overall, the safety profile in the study was consistent with that seen in previous pivotal studies of Avastin across tumour types, except for an increase in gastrointestinal-vaginal fistulas observed in patients who received Avastin plus chemotherapy compared to those who received chemotherapy alone (8.3% vs. 0.9% respectively). All patients with gastrointestinal-vaginal fistulas after treatment with Avastin plus chemotherapy had a history of prior pelvic radiation.

About cervical cancer

It is estimated that more than 33,000 new cases of cervical cancer will be diagnosed in the EU this year, and about 13,000 women will die from the disease.3 There is a dramatic difference in survival rates between early and advanced cervical cancer. At least nine out of 10 women will live for five years following a diagnosis of early stage disease, but the survival rate drops to below one in six women when the disease has spread to other parts of the body (metastasis).

Worldwide, it is estimated that there are more than half a million cases of cervical cancer yearly.4 Each year there are over 260,000 deaths from the disease, making it the fourth leading cause of cancer death in women around the world.4

About Avastin

With the initial approval in the United States 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 United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in the United States 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 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

About Avastin – mechanism 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. 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.

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, 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 Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 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 roche.com.

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

Additional information
Roche in Oncology: www.roche.com/media/media_backgrounder/media_oncology.htm

References
1.Roche data on file
2.National Cancer Institute. Surveillance, Epidemiology and End Results program (SEER) Stat Fact Sheets: Cervix Uteri Cancer. Last accessed February 2015 at http://seer.cancer.gov/statfacts/html/cervix.html
3.European Cancer Observatory: Cancer Incidence, Mortality, Prevalence and Survival in Europe. Cervical cancer. Last accessed February 2015 at http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=25&Gender=2
4.GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Last accessed February 2015 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx