Roche’s Tecentriq as a first-line monotherapy helped certain people with advanced non-small cell lung cancer live longer compared with chemotherapy
- Data will be shared with health authorities globally, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)Bullet
Basel, 12 September 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive data from the Phase III IMpower110 study evaluating Tecentriq® (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (Wild-Type or WT). The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant overall survival (OS) benefit in people with high PD-L1 expression (TC3/IC3-WT), compared with chemotherapy alone. Safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified. The study will continue to final analysis for patients with lower levels of PD-L1 expression.
“We are encouraged that Tecentriq monotherapy has shown a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings reinforce the potential of Tecentriq to play an important role in the treatment of multiple forms of lung cancer, and we look forward to discussing these data with health authorities.”
Roche will now submit these data to global health authorities, including the FDA and EMA, and will discuss how best to bring this option to patients as quickly as possible. These data will be presented at an upcoming medical congress.
Currently, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq as a monotherapy or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (Wild-Type or WT).
A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:
- Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator) or
- Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).
Lung cancer is the leading cause of cancer death globally 1. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day 1. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases 2. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope 2.
About Tecentriq (atezolizumab)
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 (CIT) 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 metastatic triple-negative breast cancer.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
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.
 GLOBOCAN 2018; Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. World Health Organization. Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed September 2019.
 American Cancer Society; What Is Non-Small Cell Lung Cancer? [Internet]: Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html Accessed September 2019.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: firstname.lastname@example.org
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Daniel Grotzky
- Karsten Kleine
- Nathalie Meetz
- 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
The Nomination Committee's proposal regarding Board of Directors and auditor of Oasmia Pharmaceutical AB for AGM 201915.9.2019 21:00:00 CEST | Press release
Oasmia's Nomination Committee has informed the company of its proposal regarding Board of Directors and auditor ahead of the Annual General Meeting September 26, 2019. The Nomination Committee proposes Hege Hellström and Anders Härfstrand as new board members. In addition, the nomination committee proposes re-election of the current Board members Jörgen Olsson, Peter Zonabend, Gunilla Öhman and Sven Rohmann. Jörgen Olsson is proposed to be re-elected as Chairman of the Board. Hege Hellström has worked at the biotechnology company Sobi since 2013 and was president for EMENAR (Europe, Middle East, North Africa and Russia). Prior to that, she was globally responsible for the Cardiovascular business area within Sanofi, VP Renal Europe and Head of Regional Liaisons, Sanofi, VP Renal and Endocrine Europe, Genzyme, General Manager Benelux Genzyme. Before Genzyme, she was 13 years at Baxter. Hege Hellström is 54 years old and has a degree in Bioengineering from Ullevaal School of Bioengineerin
Valberedningens förslag till styrelse och revisor för Oasmia Pharmaceutical AB inför årsstämman 201915.9.2019 21:00:00 CEST | Pressemelding
Oasmias valberedning har informerat bolaget om sitt förslag avseende styrelse och revisor inför årsstämman den 26 september 2019. Valberedningen föreslår Hege Hellström och Anders Härfstrand till nya styrelseledamöter. Därutöver föreslås omval av de nuvarande styrelseledamöterna Jörgen Olsson, Peter Zonabend, Gunilla Öhman och Sven Rohmann. Jörgen Olsson föreslås bli omvald som styrelsens ordförande. Hege Hellström har sedan 2013 arbetat på bioteknikbolaget Sobi som chef för EMENAR (Europa, Mellanöstern, Nordafrika och Ryssland). Dessförinnan har hon varit globalt ansvarig för affärsområdet Cardiovascular inom Sanofi, VP Renal Europa och Head of Regional Liaisons på Sanofi samt VP Renal and Endocrine Europe och General Manager Benelux på Genzyme. Innan Genzyme var hon 13 år på Baxter. Hege Hellström är 54 år och har utbildning i Bio-engineering från Ullevaal School of Bioengineering, Oslo, Norge samt en utbildning i marknadsföring och finansiering vid BI, Norwegian Business School. And
SFL - Change of name to SFL Corporation Ltd. approved13.9.2019 22:55:00 CEST | Press release
SFL Corporation Ltd. (the “Company”) today announced that its 2019 Annual General Meeting resolved to change the name of the Company from “Ship Finance International Limited” to “SFL Corporation Ltd.”. The Company’s common shares will continue to trade under the ticker “SFL” on the New York Stock Exchange. ISIN and instrument ID for the Company's listed securities remain unchanged. September 13, 2019 The Board of Directors SFL Corporation Ltd. Hamilton, Bermuda Investor and Analyst Contacts: Aksel Olesen, Chief Financial Officer, SFL Management AS +47 23 11 40 36 André Reppen, Senior Vice President, SFL Management AS +47 23 11 40 55 Media Contact: Ole B. Hjertaker, Chief Executive Officer, SFL Management AS +47 23 11 40 11 About SFL SFL has a unique track record in the maritime industry, being consistently profitable and paying dividends every quarter since 2004. The Company’s fleet of more than 90 vessels is split between tankers, bulkers, container vessels and offshore assets, and SF
SFL - 2019 Annual General Meeting13.9.2019 22:10:00 CEST | Press release
SFL Corporation Ltd. (the “Company”) advises that the 2019 Annual General Meeting of the Shareholders of the Company was held on September 13, 2019 at 10:30 a.m. at the Hamilton Princess and Beach Club, 76 Pitts Bay Road, Hamilton HM CX, Bermuda. The audited consolidated financial statements for the Company for the year ended December 31, 2018 were presented to the Meeting. In addition, the following resolutions were passed: 1. To set the maximum number of Directors to be not more than eight. 2. To resolve that vacancies in the number of Directors be designated as casual vacancies and that the Board of Directors be authorised to fill such vacancies as and when it deems fit. 3. To re-elect Harald Thorstein as a Director of the Company. 4. To re-elect Bert M. Bekker as a Director of the Company. 5. To re-elect Gary Vogel as a Director of the Company. 6. To re-elect Keesjan Cordia as a Director of the Company. 7. To re-elect James O’Shaughnessy as a Director of the Company. 8. To approve
FRO – 2019 Annual General Meeting13.9.2019 19:27:00 CEST | Press release
Frontline Ltd. (the “Company”) advises that the 2019 Annual General Meeting of the Shareholders of the Company was held on September 13, 2019 at 10:00 a.m. at the Hamilton Princess and Beach Club, 76 Pitts Bay Road, Hamilton HM CX, Bermuda. The audited consolidated financial statements for the Company for the year ended December 31, 2018 were presented to the Meeting. In addition, the following resolutions were passed: To set the maximum number of Directors to be not more than eight. To resolve that vacancies in the number of Directors be designated as casual vacancies and that the Board of Directors be authorised to fill such vacancies as and when it deems fit. To re-elect John Fredriksen as a Director of the Company. To re-elect James O’Shaughnessy as a Director of the Company. To re-elect Ulrika Laurin as a Director of the Company. To re-elect Ola Lorentzon as a Director of the Company. To re-appoint PricewaterhouseCoopers AS of Oslo, Norway as auditors and to authorise the Director
Presentation och videointervju med Arcomas VD från Bolagsdagen den 12:e september.13.9.2019 19:04:00 CEST | Pressemelding
Arcomas VD Jesper Söderqvist presenterade Arcoma på Bolagsdagen på Erik Penser Bank den 12:e september 2019. Nu finns presentation och videointervju tillgänglig. Se presentationen här Se videointervjun här Om Arcoma Arcoma, med lång erfarenhet av branschen, är en ledande leverantör av integrerade digitala röntgensystem med hög kvalitet och avancerad teknik. Arcomas produkter erbjuder den senaste digitala bildtekniken kombinerat med tekniskt avancerade rörliga positioneringssystem, vilket tillsammans med ergonomisk skandinavisk design, erbjuder kunden kompletta, konfigurerbara och funktionella digitala röntgensystem. Bolagets produkter säljs via återförsäljare samt via OEM-kunder och det finns idag över 3 500 av Arcomas röntgensystem installerade i hela världen. Arcoma är listat på Nasdaq First North Growth Market. Certified Adviser är Erik Penser Bank (tel: 08-4638300, e-mail: email@example.com) För mer information om bolaget besök www.arcoma.se