Roche launches VENTANA PD-L1 (SP142) Assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq
- This launch represents an important step in Roche’s personalised healthcare strategy to fit treatments to patients who can benefit most from a specific medicine
- Each year 300,000 patients around the world are diagnosed with triple-negative breast cancer, an aggressive disease with limited treatment options1,2
- VENTANA PD-L1 (SP142) Assay helps identify triple-negative breast cancer patients most likely to benefit from treatment with Tecentriq plus chemotherapy
Basel, 29 August 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expanded use of the VENTANA PD-L1 (SP142) Assay3,4 in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine Tecentriq® is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab)5 plus chemotherapy (nab-paclitaxel).6 Assessment of PD-L1 biomarker status on tumour-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.
Today’s announcement follows the U.S. Food and Drug Administration approval of the assay in March 2019 as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination. A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumour.
“Until recently, the only treatment option for metastatic triple-negative breast cancer patients was chemotherapy,” said Thomas Schinecker, Head of Roche Diagnostics. “With our expanding menu of companion diagnostics and targeted cancer immunotherapies, Roche is proud to continue to deliver on our mission to make personalised healthcare a global reality, ensuring the right treatment for the right patient at the right time.”
The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumour-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumour-infiltrating immune cells rather than on tumour cells themselves.7
Launched in 2016, the VENTANA PD-L1 (SP142) Assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in Tecentriq clinical trials. It was the enrollment assay used in the IMpassion130 trial, the first positive phase III immunotherapy regimen study in triple-negative breast cancer. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumour microenvironment.8
About the VENTANA PD-L1 (SP142) Assay
The VENTANA PD-L1 (SP142) Assay is available on the fully automated BenchMark IHC/ISH series instruments and uses the OptiView DAB IHC Detection Kit with OptiView Amplification Kit. The VENTANA PD-L1 (SP142) Assay performs specific staining of tumour cells and immune cells. The assay was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma (UC)5 and as a predictive assay in non-small cell lung cancer (NSCLC) with Tecentriq. See the Tecentriq product label for more information on PD-L1 expression levels in therapeutic guidance for various cancer indications.
About the IMpassion130 study
The IMpassion130 study is a phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer (mBC). For details of the study go to www.roche.com/.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.
Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.
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. More than 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.
All trademarks used or mentioned in this release are protected by law.
 Bray F, Ferlay J, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
 Eliyatkin N, Yalcin E, et al. Molecular Classification of Breast Carcinoma: From Traditional, Old-Fashioned Way to A New Age, and A New Way. J Breast Health. 2015;11(2):59-66.
 This product is intended for in vitro diagnostic (IVD) use.
 VENTANA PD-L1 (SP142) Assay may not be available for some indications and/or cutoffs in all geographies.
 In Switzerland Tecentriq is approved for non-small cell lung cancer only.
 Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]
 Emens, et al. SABCS 2018 (Abstract GS1-04)
 The PD-L1 (SP142) Assay is proven to identify patients most likely to respond to treatment with Tecentriq, as demonstrated by higher overall response rates in Cohort 2 of the IMvigor 210 clinical trial. The novel approach uses immunohistochemistry (IHC) technology designed to visually enhance and score PD-L1 protein on tumour-infiltrating immune cells. In an analysis based on 14.4 months of median follow up, Tecentriq shrank tumours (ORR) in 15 percent (95% CI: 11, 19) of people evaluable for efficacy (n=310) whose disease progressed after platinum-based chemotherapy. Tecentriq shrank tumours in 26 percent (95% CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100).
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: firstname.lastname@example.org
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Karsten Kleine
- Barbara von Schnurbein
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Brunel stops activities in BIS - Earnings outlook substantially adjusted downwards22.10.2019 20:00:00 CEST | Press release
Amsterdam, 22 October 2019 BIS activities are loss-making and causing one-off costs Profitability further under pressure due to the performance in the Netherlands and expected tougher conditions in Germany After careful consideration, Brunel has decided to stop Brunel Industrial Services (BIS) in Texas, US. Since 2017, BIS has worked on various construction and maintenance projects, including large projects in shale oil & gas. As announced in Brunel´s Q2 results this August, we encountered issues with a project for a water treatment plant, which we won in 2018, leading to a one-off loss of EUR 5.5 million. We replaced the general manager and rebuild the organization, but at the same time we saw the market for shale oil & gas experiencing a slowdown with changing clients’ behavior in their contracting model from T&M to fixed pricing. As a consequence, our BIS-activities in Q3 were at a very low level, causing a disbalance with our organizational capacity and resulting in significant ope
Telenor Group and NENT Group to merge Canal Digital and Viasat Consumer22.10.2019 19:14:00 CEST | Press release
(Fornebu/Stockholm, 22 October 2019) Telenor Group and Nordic Entertainment Group (NENT Group) today announced the formation of a new company that combines Canal Digital and Viasat Consumer (satellite pay-TV & broadband-TV operations). This will create a vibrant Nordic TV distribution business and capture synergies in a maturing direct-to-home (DTH) segment. Telenor and NENT Group will each hold 50 percent of the new company. Highlights: The combination generates a Nordic player with combined net sales of approximately NOK 7 billion and around 1.25 million subscribers (Q2 2019). The combination is expected to yield peak annual cost synergies of approximately NOK 600 million, with full effect from 2022. Integration and other related costs are expected to total approximately NOK 830 million. The company will be headquartered in both Oslo and Stockholm, and will also have a substantial presence in Copenhagen. The joint venture will operate at arm’s length to its parents. The Nordic consum
Telenor og NENT slår sammen Canal Digital og Viasat Consumer22.10.2019 19:14:00 CEST | Pressemelding
(Fornebu / Stockholm, 22. oktober 2019) Telenor og Nordic Entertainment Group (NENT) kunngjør i dag opprettelsen av et nytt selskap som kombinerer Canal Digital og Viasat Consumer (satellitt- og bredbånds-TV). Dette vil skape en fremoverlent nordisk TV-distribusjonsvirksomhet og hente synergier i et modent direct-to-home segment (DTH). Telenor og NENT vil hver eie 50 prosent av det nye selskapet. Nøkkeltall Transaksjonen resulterer i et selskap med en total omsetning på ca 7 milliarder NOK og i overkant av 1,25 millioner kunder (Q2 2019). Transaksjonen er forventet å gi årlige synergier på inntil 600 millioner NOK med helårseffekt fra 2022. Det er forventet inntil 830 millioner NOK i integrasjonskostnader. Selskapet vil ha hovedkontorer i både Oslo og Stockholm, og vil også ha en betydelig tilstedeværelse i København. Selskapet vil operere på armlengdes avstand i forhold til eierne. Det nordiske kundetilbudet vil fokusere på satellittdistribuert betal-TV (DTH) og strømmetjenester, sam
Scanship Holding ASA : Presentation of 3Q 2019 Trading update, including contract awards on 22 October22.10.2019 16:59:00 CEST | Press release
Please find enclosed the presentation of the 3Q 2019 Trading update for Scanship Holding ASA, including the contract awards received the 22 October on the order backlog. For further queries, please contact: Henrik Badin - CEO Scanship Holding ASA Tel: +47 90 78 98 25 Email: email@example.com ABOUT SCANSHIP HOLDING ASA Scanship delivers world leading solutions for cleaner oceans in the Cruise and Aquaculture industries. Scanship provides advanced technologies for processing waste and purifying wastewater. Owners operating Scanship systems have the solution to convert all waste and wastewater into clean energy and purified water which meets the highest international discharge standards. Any residuals from the Scanship processes can be recovered for reuse. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. Attachment 22102019_Scanship Holding ASA - 3Q2019 Trading Update with contract awards after presentation
European Commission has published a decision on the compatible state aid22.10.2019 16:58:00 CEST | Press release
European Commission has published a decision on the compatible state aid confirming that the measures proposed by the Republic of Lithuania to reduce the costs of maintenance of LNG terminal are compatible with the internal market and fulfil the criteria for state aid. The measures approved in this decision will create legal preconditions to reduce the costs of maintenance of LNG terminal by the amount of up to EUR 135,5 mln. until 2024. Further decisions will be approved by the Board and the General Meeting of Shareholders of AB Klaipedos nafta. More information on the approval of the European Commission is provided on the following: https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=3_SA_53074 Jonas Lenkšas, Chief Financial Officer, +370 694 80594
Scanship Holding ASA : Scanship awarded clean ship system contracts and increases backlog to new record high22.10.2019 15:45:00 CEST | Press release
Scanship Holding ASA, through its subsidiary Scanship AS, has been awarded contracts with an European shipbuilder for the supply of a total Scanship clean ship system for two luxury and expedition class type of cruise ships. The newbuilds will enter service in 2022 and 2023. The contracts also include options for further deliveries to 6 newbuilds planned to enter service from 2024 and onwards. The luxury vessels will be delivered to one of the major US based shipowners. More details will be announced in relation to these contracts at a later stage. The Scanship contracts includes delivery of systems for food waste processing, garbage handling and wastewater purification, to meet the industry's highest environmental regulations worldwide and particularly the new regulations now being enforced in the Baltic Sea. This latest order intake accumulates the total order backlog to a record high level of NOK 710 million firm and NOK 570 million of optional contracts. For further queries, please