Roche to present new data from its industry-leading oncology portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

• New and updated pivotal combination data from the Tecentriq lung programme, including overall survival (OS) results from IMpower150 and progression free survival (PFS) results from IMpower131
• New, longer follow-up data from the Phase III ALEX study of Alecensa in ALK-positive lung cancer
• Pivotal data from the haematology clinical development programme, including new data for Venclexta and polatuzumab vedotin
• Key highlights to be shared at Roche’s ASCO Media Briefing on 1 June 2018, from 09:00 - 10:45 CDT at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States. More than 180 abstracts have been accepted across 13 cancer types, including two “late breakers” and 15 oral presentations.

“New data to be presented from our industry-leading oncology portfolio, including our lung and haematology programmes, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “At ASCO, we look forward to sharing our progress and commitment to build the future of personalised healthcare in oncology.”

Further information on Roche’s contribution to the ASCO 2018 scientific programme, as well as Roche’s wider progress in cancer care, will be featured during the Roche Media Briefing from 09:00 - 10:45 CDT on Friday, 1 June at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to journalists from outside the United States who have registered as media with the ASCO 2018 Annual Meeting. To register for the Roche Media Briefing, please follow this link: https://roche.cvent.com/d/6gq8k1/.

Follow Roche on Twitter via @Roche and keep up to date with ASCO 2018 congress news and updates by using the hashtag #ASCO18.

Key presentations in lung cancer

Key data to be presented at ASCO cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy, Tecentriq® (atezolizumab) with targeted therapies and a range of different chemotherapies.

Updated OS data and new patient reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin® (bevacizumab) and chemotherapy (carboplatin and paclitaxel), in people with previously-untreated, advanced non-squamous non-small cell lung cancer (NSCLC), will be presented. The US Food and Drug Administration (FDA) recently granted Priority Review for this combination in the same patient population.

New PFS results from the Phase III IMpower131 study of Tecentriq plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with advanced squamous NSCLC will also be shared and feature as part of ASCO’s official press programme on Saturday, 2 June.

Additional results in lung cancer include longer follow-up results from the Phase III ALEX study of Alecensa® (alectinib) versus crizotinib in people with previously untreated anaplastic lymphoma kinase (ALK)-positive NSCLC. These data build on the primary results from the ALEX study, first presented at ASCO 2017, which demonstrated a significant reduction in the risk of disease progression or death versus crizotinib. New data that utilise the application of a real world endpoint to identify and characterise genetic profiles of people with a poor prognosis in advanced NSCLC will also be presented at the congress.

Additional presentations with cancer immunotherapy

Additional cancer immunotherapy data presentations of note include new Tecentriq plus Avastin PROs from the Phase III IMmotion151 study in advanced renal cell carcinoma (RCC), and Phase Ib data for the combination of Tecentriq plus Avastin in first-line hepatocellular carcinoma (HCC). These studies add to the growing body of evidence that support the use of Tecentriq plus Avastin across multiple tumour types.

New tumour mutational burden (TMB) data from two studies of Tecentriq will also be presented, including blood-based TMB data from the Phase II B-F1RST study in advanced NSCLC, and tissue-based TMB data across multiple tumour types including NSCLC, metastatic urothelial carcinoma and melanoma.

Key presentations in blood cancers

Data from pivotal studies in haematology will also be presented at ASCO. Additional analyses on minimal residual disease (MRD) rates will be shared from the Phase III MURANO study evaluating Venclexta®/Venclyxto™ (venetoclax) plus MabThera®/Rituxan® (rituximab), compared to bendamustine plus MabThera/Rituxan, in people with relapsed or refractory chronic lymphocytic leukaemia (CLL). A supplemental new drug application (sNDA) based on the MURANO data was granted Priority Review by the FDA, with an action date of 28 June 2018.

Additional data will also be presented from the Phase Ib M14-358 study of Venclexta/Venclyxto plus azacitidine or decitabine in people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Data from the randomised Phase II study evaluating polatuzumab vedotin in combination with bendamustine chemotherapy and MabThera/Rituxan in people with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) will also be presented at the meeting.

Key presentations in breast cancer

Updates from two investigational medicines in breast cancer will be presented at ASCO. Data includes results from the Phase III SANDPIPER study of taselisib (GDC-0332) and fulvestrant, compared to fulvestrant alone, in estrogen receptor (ER)-positive, PIK3CA-mutant, locally advanced or metastatic breast cancer, and updated OS data from the LOTUS trial of ipatasertib (GDC-0068, RG7440) and paclitaxel for previously untreated, locally advanced or metastatic, triple-negative breast cancer. The SANDPIPER data will be featured as part of ASCO’s official press programme on Saturday, 2 June.

Overview of key presentations featuring Roche medicines at ASCO 2018

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®/Venclyxto™ (venetoclax); Xeloda® (capecitabine); Zelboraf® (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

For more information on Roche’s approach to cancer, visit Roche.com.

About Roche

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

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.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty 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 nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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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