Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

• Study results across 17 medicines reflect our commitment to personalised care with advances in targeted therapies, immunotherapy, and diagnostics, data and analytics
• New pivotal data on fixed-duration combination of Venclexta/Venclyxto plus Gazyva/Gazyvaro in previously untreated chronic lymphocytic leukaemia
• New data for entrectinib in paediatric patients with recurrent or refractory solid tumours harbouring NTRK, ROS1 or ALK gene fusions

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, United States, from 31 May– 4 June, 2019. A total of 155 abstracts that include a Roche medicine will be presented at this year's meeting.

“At this year’s ASCO meeting, we are excited to present new data with targeted therapies, immunotherapy and pipeline combinations across a broad range of diseases including blood, breast and lung cancers, as well as paediatric tumours treated with our personalised cancer medicine, entrectinib,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “Through pioneering science, strategic partnerships and data and analytics, we’re striving to develop transformative medicines that can help improve outcomes for each individual patient."

Further information on Roche’s contribution to the ASCO 2019 scientific programme, as well as the latest innovations and developments in Roche’s approach to accelerating progress in cancer care, will be featured during the Roche analyst event from 6:00 - 7:15 pm CDT on Monday 3 June at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to analysts and investors who have registered with the ASCO 2019 Annual Meeting. To register for the event, please follow the link (Password: Analyst2019).

Keep up to date on ASCO meeting news and updates by following Roche on Twitter via @Roche and using the hashtag #ASCO19.

Key presentations in blood cancers

The first data from the pivotal Phase III CLL14 study will be presented at ASCO, evaluating the 12-month, fixed-duration, chemotherapy-free combination of Venclexta^®/Venclyxto^® (venetoclax) plus Gazyva^®/Gazyvaro^® (obinutuzumab) compared to Gazyva/Gazyvaro plus chlorambucil in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The US Food and Drug Administration (FDA) is reviewing a supplemental New Drug Application (sNDA) based on results of the CLL14 study under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche group, in the US and commercialised by AbbVie outside of the US.

Key presentations in paediatric cancers

The first data from the Phase I/II STARTRK-NG study of the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK)-positive tumours, including central nervous system tumours, will be presented. The study enrolled children and adolescents aged 4.9 months through 20 years (median of seven years) across several different cancer types, including some rare tumours. The STARTRK-NG data will be featured as part of ASCO’s official press programme on Wednesday, 15 May.

The FDA recently granted Priority Review for entrectinib for the treatment of paediatric and adult patients with NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). These NDAs are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the STARTRK-NG study. The FDA is expected to make a decision on the approval by 18 August 2019.

Key presentations in breast cancers

Key data to be presented at ASCO include updates from Roche’s breast cancer programme across multiple subtypes of the disease, including the second interim analysis of overall survival (OS) results, updated safety data and patient-reported outcomes (PROs) from the Phase III IMpassion130 study of Tecentriq^® (atezolizumab) plus chemotherapy (Abraxane^® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC). This combination was recently granted accelerated approval from the FDA based on progression-free survival (PFS) for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1, as determined by an FDA-approved test.

Additional data include an eight-year, end-of-study analysis from the Phase III CLEOPATRA study of Perjeta^® (pertuzumab) plus Herceptin^® (trastuzumab) and chemotherapy for first-line treatment of HER2-positive metastatic breast cancer.

Key presentations in lung cancers

Key data from Roche’s broad lung cancer programme will be presented across different types of the disease, including results from the Phase III IMpower150 trial of Tecentriq plus Avastin^® (bevacizumab) and chemotherapy (carboplatin and paclitaxel) in chemotherapy-naïve people previously untreated for metastatic NSCLC whose cancer has spread to the liver, which affects approximately 20% of people with the disease. Additionally, results from studies in partnership with Flatiron Health will be presented, including validation of the use of next-generation sequencing data on a broad scale to improve the understanding of clinical outcomes in people with metastatic lung cancer, and results that illustrate how real-world data can be used to supplement evidence from clinical trials in rare tumour types such as ROS1-positive lung cancer.

Key presentations featuring Roche medicines at ASCO 2019

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^TM (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 www.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. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 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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