Media Release Basel, 3 May 2016 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. F. Hoffmann-La Roche Ltd 4070 Basel Switzerland Group Communications Roche Group Media Relations Tel. +41 61 688 88 88 Fax +41 61 688 27 75 www.roche.com 1/1
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. Further information on Roche s contribution to the ASCO 2016 scientific program, as well as Roche s wider progress in cancer care, will be featured during the Roche media briefing from 10:45-12:30 CDT on Friday 3 rd June at the Chicago Marriott Hotel Downtown Magnificent Mile. This event, independently organized by Roche, is open to journalists from outside the United States who have registered as media with the ASCO 2016 Annual Meeting. To register, please follow this link. 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 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) Updated efficacy and > 1-y follow up from IMvigor210: Atezolizumab (atezo) in platinum (plat) treated locally advanced/metastatic urothelial carcinoma (muc). Updated survival and biomarker analyses of a randomized phase II study of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR) Correlation of peripheral and intratumoral T-cell receptor (TCR) clonality with clinical outcomes in patients with metastatic urothelial cancer (muc) treated with atezolizumab. A phase Ib dose escalation study of the OX40 agonist Abstract 4515 (oral) Abstract 9028 (poster) Saturday, 4th June 08:00-11:30 CDT Abstract 3005 (oral) 13:15-16:15 CDT Abstract 101 (oral) 2/2
Alecenca (alectinib) Avastin (bevacizumab) ipatasertib MabThera / Rituxan (rituximab) Venclexta (venetoclax) MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors. Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC). Phase Ib trial of atezolizumab in combination with nabpaclitaxel in patients with metastatic triple negative breast cancer (mtnbc) 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 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 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) 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 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 Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged 65 years with acute myelogenous leukemia Phase 1b study of venetoclax plus R- or G-CHOP in patients with B-cell non-hodgkin lymphoma 08:00-09:30 CDT Abstract 3502 (oral) Abstract 1009 (poster 16:45-18:00 CDT Abstract 9008 (oral) 9:45-12:45 CDT Abstract 1013 (poster 16:45-18:00 CDT Abstract 5017 (poster 13:00 16:30 CDT Abstract 10507 (oral) Friday, 3 June 15:00-18:00 CDT Abstract 7009 (poster 11:30-12:45 CDT Abstract 7007 (oral) 15:00-18:00 CDT Abstract 7566 (poster) 8:00-11:30 CDT 3/3
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, 4/4
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. All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: roche.mediarelations@roche.com - Nicolas Dunant (Head) - Catherine Dürr - Ulrike Engels-Lange - Nicole Rüppel - Anja von Treskow 5/5