Roche highlights personalised medicines and cancer immunotherapies at 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

• 19 Roche medicines are included in more than 200 abstracts during ASCO 2016
• New results for cancer immunotherapy atezolizumab in bladder cancer and other cancer types
• Early results for atezolizumab in combination with targeted medicines and the investigational cancer immunotherapy MOXR0916, an OX40 agonist
• Superiority results from Phase III study comparing Alecensa™ (alectinib) to crizotinib

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from 3rd – 7th June in Chicago, United States. More than 200 abstracts have been accepted across eight cancer types, including four “late breakers” and nearly 30 oral presentations.

“The confluence of new medicines, sophisticated diagnostics and advanced technologies has created an unprecedented opportunity to improve outcomes for patients today and in the future,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At this year’s ASCO meeting, we look forward to presenting results from studies that have the potential to define new treatment approaches for cancers that have not seen significant progress in decades.”

New trial results for atezolizumab include data from a study in which people received the medicine as an initial treatment for metastatic bladder cancer (first-line). These data will be highlighted as part of ASCO’s official press program. New overall survival and diagnostic results will be presented in recurrent metastatic bladder and lung cancer, and results from early combination studies of atezolizumab with targeted medicines and the investigational cancer immunotherapy MOXR0916, an OX40 agonist, will also be featured.

Roche will be presenting data from the J-ALEX trial, an open-label, randomised phase III study that compared Alecensa and crizotinib in people with ALK-positive advanced or recurrent NSCLC who had not previously received an ALK inhibitor and who had a maximum of one prior treatment with a chemotherapy.

Results for Roche’s haematology medicines include data from a study of MabThera®/Rituxan® in children with high risk B-cell non-Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL). Results from Phase I/II studies of Venclexta™ (venetoclax) in acute myeloid leukemia (AML), as well as the first data from a phase 1b study of Venclexta in B-cell NHL in combination with either MabThera/Rituxan and CHOP chemotherapy or Gazyva®/Gazyvaro® and CHOP chemotherapy, will also be presented. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

An analyst briefing to discuss key data presented on the Roche Group's oncology products and pipeline at ASCO 2016 will take place on Sunday 5 June from 6:30 -8:00 pm CDT at the Marriott Downtown Chicago Magnificent Mile. This event, independently organized by Roche, is open to analysts and investors who have registered for the event. To register for the event, please follow the link (Password: Analyst2016)

Follow Roche on Twitter via @Roche and keep up to date with ASCO 2016 Annual Meeting news and updates by using the hashtag #ASCO16.

Overview of key presentations featuring Roche medicines at ASCO 2016

Medicine	Abstract title	Abstract number
Atezolizumab (investigational use)	Atezolizumab (atezo) as first-line (1L) therapy in cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (mUC): Primary analysis of IMvigor210 cohort 1.	Abstract LBA4500 (oral) Sunday, 5 June 08:00-11:00 CDT
	Updated efficacy and > 1-y follow up from IMvigor210: Atezolizumab (atezo) in platinum (plat) treated locally advanced/metastatic urothelial carcinoma (mUC).	Abstract 4515 (oral) Sunday, 5 June 08:00-11:00 CDT
	Updated survival and biomarker analyses of a randomized phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR).	Abstract 9028 (poster) Saturday, 4th June 08:00-11:30 CDT
	Correlation of peripheral and intratumoral T-cell receptor (TCR) clonality with clinical outcomes in patients with metastatic urothelial cancer (mUC) treated with atezolizumab.	Abstract 3005 (oral) Saturday, 4 June 13:15-16:15 CDT
	A phase Ib dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors.	Abstract 101 (oral) Saturday, 4 June 08:00-09:30 CDT
	Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC).	Abstract 3502 (oral) Sunday, 5 June 08:00-11:00 CDT
	Phase Ib trial of atezolizumab in combination with nab-paclitaxel in patients with metastatic triple negative breast cancer (mTNBC)	Abstract 1009 (poster discussion) Sunday, 5 June 16:45-18:00 CDT
Alecensa (alectinib) (investigational use)	Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC): primary results from the J-ALEX study	Abstract 9008 (oral) Monday, 6 June 9:45-12:45 CDT
Avastin® (bevacizumab)	Overall survival of patients with HER2-negative metastatic breast cancer treated with a first-line paclitaxel with or without bevacizumab in real-life setting: Results of a multicenter national observational study	Abstract 1013 (poster discussion) Sunday, 5 June 16:45-18:00 CDT
ipatasertib (investigational use)	Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study)	Abstract 5017 (poster discussion) Saturday, 4 June 13:00 – 16:30 CDT
MabThera / Rituxan (rituximab) (investigational use)	Results of the randomized Intergroup trial Inter-B-NHL Ritux 2010 for children and adolescents with high risk B-cell non Hodgkin lymphoma (B-NHL) and mature acute leukemia (B-AL): Evaluation of rituximab (R) efficacy in addition to standard LMB chemotherapy (CT) regimen	Abstract 10507 (oral) Friday, 3 June 15:00-18:00 CDT
Venclexta (venetoclax) (investigational use)	Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥65 years ineligible for standard induction therapy	Abstract 7009 (poster discussion) Monday, 6 June 11:30-12:45 CDT
	Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged ≥65 years with acute myelogenous leukemia	Abstract 7007 (oral) Saturday, 4 June 15:00-18:00 CDT
	Phase 1b study of venetoclax plus R- or G-CHOP in patients with B-cell non-Hodgkin lymphoma	Abstract 7566 (poster) Monday, 6 June 8:00-11:30 CDT

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. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, 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 atezolizumab 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 atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

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

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: Avastin (bevacizumab); Cotellic™ (cobimetinib); Erivedge® (vismodegib); Gazyva/Gazvyaro (obinutuzumab); Herceptin® (trastuzumab); Kadcyla® (trastuzumab emtamsine); MabThera/Rituxan (rituximab); Perjeta® (pertuzumab); Tarceva® (erlotinib); 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 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.

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