Media Release

Basel, 03 October 2016

First phase III data on Roche’s TECENTRIQ (atezolizumab) to feature at the 2016 European Society for Medical Oncology (ESMO) Congress

•    Superiority results from the phase III OAK study comparing Tecentriq® to chemotherapy in a difficult to treat type of lung cancer will be highlighted at the ESMO Presidential Symposium
•    Investigational cancer immunotherapy-based combination approaches across a range of cancer types to be showcased during the congress  
•    Emerging data from multiple studies focusing on biomarker science and real-world data enhance understanding of cancer  
•    Data from 16 approved and investigational Roche medicines covering more than 20 distinct cancer types to be presented in 131 abstracts during ESMO 2016


Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new results from studies with its approved or investigational medicines across more than 20 cancer types will be presented during the European Society for Medical Oncology (ESMO) Congress from 7 – 11 October 2016 in Copenhagen, Denmark. These include the first pivotal phase III results for Tecentriq, outcomes from early studies of cancer immunotherapy-based combinations, results from clinical studies with a broad range of Roche’s investigational medicines, and new insights from studies that continue to shape a better understanding of how different types of cancer develop and affect people around the world.

“At Roche, our focus on understanding human immunology and cancer biology is helping us to develop new medicines that improve outcomes for people with cancer,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to the presentation of the pivotal OAK data for Tecentriq during ESMO’s Presidential Symposium, as well as other presentations such as new data from our collaboration with Foundation Medicine that showcase how we are expanding our understanding of each individual’s cancer.”

At ESMO, positive results from the Tecentriq phase III lung cancer study known as OAK will be presented as a “late-breaking” abstract in the ESMO Presidential Symposium 2 on Sunday, 9 October. Roche recently announced that the study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. In the United States, Roche’s Biologics License Application (BLA) for Tecentriq in NSCLC was granted Priority Review with an action date of 19 October 2016.

In addition to OAK, 19 Roche cancer immunotherapy abstracts featuring Tecentriq and other innovative molecules will be presented. This includes early data assessing Tecentriq in an investigational combination with the approved, targeted Roche medicines Zelboraf® (vemurafenib) and Cotellic® (cobimetinib) in melanoma, and as a novel investigational combination with Cotellic in colorectal cancer.

Follow Roche on Twitter via @Roche and keep up to date with ESMO 2016 congress news and updates by using the hashtag #ESMO16.

Overview of key presentations at ESMO 2016

Investigational medicine Abstract title  Abstract number 

Alecensa®
(alectinib)

Updated efficacy and safety from the global phase II NP28673 study of alectinib in patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC)

1263P
Ipatasertib (RG7440) PTEN loss as a predictive biomarker for the Akt inhibitor ipatasertib combined with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) 718O
Tecentriq  (atezolizumab)

Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC

LBA44

Atezolizumab (atezo) in platinum (plat)-treated locally advanced/metastatic urothelial carcinoma (mUC): Updated OS, safety and biomarkers from the Ph II IMvigor210 study

783P

IMvigor210: updated analyses of first-line (1L) atezolizumab (atezo) in cisplatin (cis)-ineligible locally advanced/metastatic urothelial carcinoma (mUC)​

782PD​

Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)​

871P

Efficacy and safety of cobimetinib (cobi) and atezolizumab (atezo) in an expanded phase 1b study of microsatellite-stable (MSS) metastatic colorectal cancer (mCRC)​

470P​

Preliminary safety and clinical activity of atezolizumab combined with cobimetinib and vemurafenib in BRAF V600-mutant metastatic melanoma​

1109PD

Clinical activity, safety and predictive biomarker results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)​

1425PD​

Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)​

871P​

The SP142 PD-L1 IHC assay for atezolizumab (atezo) reflects pre-existing immune status in NSCLC and correlates with PD-L1 mRNA

1171P

Tumor mutation load assessed by FoundationOne (FM1) is associated with improved efficacy of atezolizumab (atezo) in patients with advanced NSCLC 77P
Real-World Data Second-line metastatic urothelial carcinoma treatment and survival in real-world patients in the US 801P

About Roche in Oncology

Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa® (alectinib); Avastin® (bevacizumab); Cotellic® (cobimetinib); Erivedge® (vismodegib); Gazyva®/Gazyvaro (obinutuzumab); Herceptin® (trastuzumab); Kadcyla® (trastuzumab emtansine); MabThera/Rituxan® (rituximab); Perjeta® (pertuzumab); Tarceva® (erlotinib); Tecentriq® (atezolizumab); Venclexta™ (venetoclax); Xeloda® (capecitabine); Zelboraf® (vemurafenib). Furthermore the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

In addition to Roche’s innovative portfolio of cancer medicines, Roche is constantly developing new diagnostic tests that will have a significant impact on disease management for cancer patients. Within the Roche Group there are more than 350 pharmaceutical and diagnostics collaborations, far more than half of which are in the field of oncology. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreatic and lung cancer, as well as a range of tissue and molecular oncology tests that contribute to personalised cancer care today, Roche is leading a new era of innovation in the fight against cancer.

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 eight 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.


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