Investor Update

Basel, 30 May 2015

Collaborative group phase III study shows Roche’s Avastin improves survival in patients with mesothelioma – a devastating type of thoracic cancer

  • Avastin with standard of care helped patients with mesothelioma live longer
  • Data selected as a ‘Best of ASCO’ abstract, representing “relevant, cutting-edge science and education”
  • Assessment of potential for regulatory filing underway

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today phase III results from a collaborative group study that showed that patients with malignant pleural mesothelioma, a rare type of cancer that affects the lining of the lungs, lived significantly longer when treated with Avastin in combination with standard therapy (pemetrexed and cisplatin chemotherapy) compared to standard therapy alone. The study met its primary endpoint of improving overall survival with a statistically significant 24 percent reduction in the risk of death for patients who received Avastin plus standard therapy, representing a median gain in survival of 2.7 months, compared to those who received standard therapy alone (HR=0.76, p=0.0127). The data will be presented at the 51st annual meeting of the American Society of Clinical Oncology (ASCO) in an oral session by Professor Gérard Zalcman, M.D., President of the French Collaborative Thoracic Intergroup (Abstract 7500, Saturday 30th May at 15.00 pm CDT).1

Around the world, it is estimated that 14,000 patients a year are diagnosed with mesothelioma, a difficult to treat disease that is primarily associated with exposure to asbestos.2-4 Following exposure, it can take an estimated 40 years for mesothelioma to develop and show any signs or symptoms.3 Moreover, the symptoms (shortness of breath, cough and pain in the chest) are largely ambiguous and may be attributed to less serious conditions, meaning that patients with mesothelioma are generally diagnosed with advanced disease.5

“We are encouraged that Avastin in combination with chemotherapy improved survival for patients in this study compared to chemotherapy alone,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “These data represent the first advance in survival outcomes for this devastating disease in over a decade. We look forward to collaborating with the sponsors of this study to determine the potential for regulatory filing.”

“For too long, patients with mesothelioma have been underserved in terms of treatment options compared to other types of cancer. These data are an important treatment advance and may offer a potential new standard of care.” said Professor Gérard Zalcman, M.D., Principal Investigator of the study.

About the MAPS study1

MAPS (IFCT-GFPC-0701) is an independent, randomised, open label, phase III study, sponsored by the French Collaborative Thoracic Intergroup (IFCT) that assessed the efficacy and safety of pemetrexed and cisplatin chemotherapy with or without Avastin in patients with malignant pleural mesothelioma who had not been previously treated with chemotherapy. The primary endpoint was overall survival and secondary endpoints included progression-free survival (PFS), safety and quality of life (QoL). Data from 448 patients showed1:

  • The study met its primary endpoint of improving overall survival (OS) with a statistically significant 24 percent reduction in the risk of death for patients who received Avastin in combination with pemetrexed and cisplatin, representing a median gain in survival of 2.7 months, compared with those who received pemetrexed and cisplatin alone (median overall survival: 18.8 months vs. 16.1 months; (HR)=0.76, p=0.0127).1
  • The study also showed that patients treated with Avastin in combination with pemetrexed and cisplatin had significantly improved progression-free survival (PFS) compared to those treated with pemetrexed and cisplatin alone (median PFS: 9.6 months vs. 7.5 months; HR=0.61, p<0.0001).1
  • The safety profile was in line with previous data for Avastin with Grade 3-4 haematological toxicities similar in both arms (49.6% in the standard therapy arm vs. 47.3% in the Avastin arm). Proteinuria (0.0% vs. 3.2%), hypertension (0.0% vs. 23.0%), arterial thrombotic events (0.0% vs. 2.7%) were higher in the Avastin arm.1

About mesothelioma

Mesothelioma (or cancer of the lining of the lungs) is a rare cancer and with an estimated 14,000 cases across the world yearly, represents less than one percent of all cancers.2,6,7 Malignant pleural mesothelioma is the most common type of mesothelioma.4 The disease is primarily associated with asbestos exposure and the time between exposure to asbestos and diagnosis is usually between 20 and 40 years.3 Unfortunately most people are not diagnosed with mesothelioma until the cancer is in its advanced stages and treatment with surgery, chemotherapy or radiation may not be an option8. At this stage, median survival is approximately one year with current standard of care therapies.4,9

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, ovarian cancer and cervical 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 two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 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-eight 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 www.roche.com.

About The French Collaborative Thoracic Intergroup (IFCT)

Created in 1999, the French Collaborative Thoracic Intergroup (IFCT) is composed of 470 physicians from various disciplines working in the field of lung cancer. IFCT sponsors clinical studies and is supported by a national network of 250 centers (university hospitals, cancer centers, general hospitals and private clinics). IFCT trials are coordinated by a Clinical Research Unit accredited by the French National Cancer Institute (INCa) and the National League Against Cancer. Funded by various sources of public and industrial funds, IFCT is strongly committed to conducting independent studies. The IFCT in figures: 600 investigators, 250 centers across France, nearly 9,000 patients included in 28 studies since 1999, and 11 current studies with active patient recruitment. For more information on the IFCT, visit www.ifct.fr

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References
1. Zalcman G et al. Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial. Abstract number 7500.
2. Park E-K et al. Environ Health Perspect 2011; 119:4:514-518
3. Bianci C. Industrial Health 2007; 45: 379–387
4. Røe OD et al. Eur Respir Rev 2015; 24: 115–131
5. NHS. Mesothelioma. Last accessed 1 May 2015 at http://www.nhs.uk/conditions/mesothelioma/Pages/Definition.aspx
6. Delgermaa V et al. Bulletin of the World Health Organization. Last accessed 1 May 2015 at http://www.who.int/bulletin/volumes/89/10/11-086678/en/
7. WHO. GLOBOCAN 2012. Last accessed 1 May 2015 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
8. Cancer Research UK. Pleural mesothelioma treatment. Last accessed 1 May 2015 at http://www.cancerresearchuk.org/about-cancer/type/mesothelioma/treatment/types/pleural-mesothelioma-treatment
9. Vogelzang NJ et al. J Clin Oncol. 2003; 21: 2636-2644