Roche : Tecentriq® (atezolizumab) shows increasing overall survival benefit in updated clinical data analysis for people with specific type of advanced lung cancer

Basel, 4 June 2016

Roche's Tecentriq® (atezolizumab) shows increasing overall survival benefit in updated clinical data analysis for people with specific type of advanced lung cancer

• Updated overall survival (OS) benefit with Tecentriq was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy
• Follow-up data are encouraging as potential survival benefits associated with Tecentriq improve over time

Roche (SIX: RO, ROG; OTCQX: RHHBY) will today present updated survival data from the phase II study POPLAR, in people with previously treated advanced non-small cell lung cancer (NSCLC). The study results demonstrate a clear effect of Tecentriq on the likelihood of survival (Hazard Ratios, HR) with continued improvement as data mature. The earliest data analysis showed an overall survival (OS) benefit of 11.4 months (HR=0.77. CI: 95%) for Tecentriq compared to 12.6 months (HR=0.69. CI 95%) for this updated analysis. In addition, median duration of response (mDOR) has also improved with additional follow-up, from 14.3 months (HR=0.41. CI: 95%) in the initial analysis to 18.6 months (HR 0.32, CI: 95%) in the current data analysis. There were no new or unexpected safety signals, a finding consistent with earlier study results.

'These results are very encouraging because they highlight that the benefits associated with Tecentriq have increased with time, and are not restricted to people with high levels of PD-L1 expression in this type of lung cancer,' said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. 'These data show that longer follow-up is necessary to fully realise the advantages of cancer immunotherapies and traditional means to describe clinical benefit, like progression free survival, may not be the most sensitive measure for this class of treatment.'

The U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and granted Priority Review for Tecentriq for the treatment of people with locally advanced or metastatic NSCLC whose disease expresses the protein PD-L1, as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. The FDA will make a decision on approval by 19 October, 2016.

Updated results of the POPLAR study will be presented by David Smith, Compass Oncology, Vancouver, Canada (Abstract #9028) on Saturday, 4 June, 8:00-11:30 am CDT.

Further information on Roche's contribution to the ASCO 2016 scientific programme, the company's wider progress in cancer care and key data being presented at the conference will be featured at a Roche investor briefing on Sunday 5 June between 6pm - 8pm CDT. This event is independently organised by Roche and is open to analysts attending the ASCO 2016 Annual Meeting. To register for the Roche investor briefing, please use the following link:
http://www.roche.com/investors/updates/inv-update-2016-04-27.htm

To learn more about Roche's personalised cancer immunotherapy programme and Roche's contribution to ASCO 2016, please follow Roche on Twitter via @Roche. You can keep up to date with ASCO 2016 Annual Meeting news and updates by using the hashtag #ASCO16.

About the POPLAR study

POPLAR is a multicentre, open-label, randomised phase II study evaluating the efficacy and safety of Tecentriq compared with chemotherapy (docetaxel) in people with previously treated recurrent locally advanced or metastatic NSCLC. Patients were randomised to receive either Tecentriq 1200 mg intravenously every three weeks or docetaxel 75 mg/m2 intravenously every three weeks. The study enrolled 287 people with previously treated, advanced NSCLC.

The primary endpoint was OS; secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety. People were stratified by PD-L1 expression on tumour-infiltrating immune cells (ICs), histology and prior lines of therapy. PD-L1 expression was assessed for both tumour cells (TCs) and ICs; people were scored as TC0, 1, 2 or 3 and IC0, 1, 2 or 3 with a companion diagnostic immunohistochemistry (IHC) test being developed by Roche Diagnostics.

Overall Survival (OS) Benefit with Tecentriq from January 2015 - December 2015:

• January - OS benefit of 11.4 months (HR=0.77. CI: 0.55-1.06)
• May - OS benefit of 12.6 months (HR=0.73. CI: 0.53-0.99),
• December - OS benefit of 12.6 months (HR=0.69. CI: 0.52-0.92)

POPLAR updated OS data

About non-small cell lung cancer

Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, Tecentriq may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

About Roche in cancer immunotherapy

For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we're investing more than ever in our effort to bring innovative treatment options that help a person's own immune system fight cancer.

About personalised cancer immunotherapy

The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. The Roche PCI research and development programme comprises more than 20 investigational candidates, nine of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for Roche medicines. In the case of Tecentriq, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with Tecentriq as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit. The ability to combine Tecentriq with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

PCI is an essential component of how Roche delivers on the broader commitment to personalised healthcare.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. 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.