GlobeNewswire by notified

New Phase III data support the benefit of Roche’s Tecentriq in early-stage lung cancer

Share
  • Data presented at the 2021 ESMO Virtual Congress and the IASLC 2021 WCLC add to the body of evidence supporting Tecentriq’s role in treating early-stage lung cancer
  • As published in The Lancet, Tecentriq is the first and only cancer immunotherapy to demonstrate positive Phase III results in the adjuvant lung cancer setting
  • Tecentriq was granted Priority Review by the FDA and is currently being reviewed under the Real-Time Oncology Review pilot programme

Basel, 20 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

“Today, more than half of all people with early-stage NSCLC experience recurrence following surgery,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “IMpower010 shows how, for the first time, a cancer immunotherapy may help many of these patients live longer without their disease returning. The data presented at ESMO and WCLC further contribute to our understanding of Tecentriq in this treatment setting.”

At the 2021 ESMO Virtual Congress, new real-world data show that almost three-quarters of patients with early-stage NSCLC in the US did not receive adjuvant treatment, despite guideline recommendations.1 Data presented from IMpower010 show that adjuvant Tecentriq offers a DFS benefit in the Stage II-IIIA patient population, irrespective of the stage of disease and across the main prior therapies.2 Specifically, time to relapse appeared to be improved with Tecentriq, compared with BSC, among people with Stage II-IIIA NSCLC whose tumours express PD-L1 TC ≥1%, for both locoregional and distant sites. There was no clear difference in patterns of relapse. An extended analysis of PD-L1 subgroups in the Stage II-IIIA population shows there is a higher magnitude of benefit from adjuvant Tecentriq in people with PD-L1 expression ≥50%, compared with those with 1-49% PD-L1 expression. The exploratory nature of the analysis in patients with 1-49% PD-L1 expression prevents any firm conclusions, and these data will be further analysed and shared at a future medical congress.

Additional IMpower010 data, recently presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) Presidential Symposium, showed that treatment with Tecentriq improved DFS in the PD-L1≥1% Stage II-IIIA NSCLC population, compared with BSC, regardless of most surgery types and adjuvant chemotherapy regimens.3

Based on the IMpower010 data, the US Food and Drug Administration (FDA) recently granted Priority Review to Tecentriq as an adjuvant treatment for certain people with early NSCLC and is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA is expected to make a decision on approval by 1 December 2021.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower010 study
IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About NSCLC
Lung cancer is one of the leading causes of cancer death globally.4 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.4 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 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.5

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (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 NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm

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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies 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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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.

All trademarks used or mentioned in this release are protected by law.

References
[1] Lee JM, et al. Real-World Adjuvant Treatment Patterns and Survival Outcomes Among Early NSCLC US Patients [ESMO 2021 Abstract #1600]
[2] Felip E, et al. IMpower010: Sites of Relapse and Subsequent Therapy From a Phase 3 Study of Atezolizumab vs Best Supportive Care After Adjuvant Chemotherapy in Resected Stage IB-IIIA NSCLC [ESMO 2021 Abstract #LBA9].
[3] Altorki N, et al. IMpower010: Characterization of Stage IB-IIIA NSCLC Patients by Type and Extent of Therapy Prior to Adjuvant Atezolizumab [WCLC 2021 Abstract #PL02.05].
[4] World Health Organization: GLOBOCAN 2020 – Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. [Internet; cited September 2021] Available from: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf
[5] American Cancer Society: What Is Lung Cancer? [Internet; cited September 2021] Available from: https://www.cancer.org/cancer/lung-cancer/about/what-is.html


Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
Patrick Barth
Phone: +41 61 688 44 86

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Karsten Kleine
Phone: +41 61 682 28 31

Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 61 687 43 05


Roche Investor Relations
Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com
Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com

Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified 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 by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Nokia selected by T-2 Slovenia in five-year 5G deal as sole supplier18.10.2021 10:00:00 CEST | Press release

Press Release Nokia selected by T-2 Slovenia in five-year 5G deal as sole supplier Nokia to expand T-2’s Single RAN footprint and introduce enhanced 5G services across the country 18 October 2021 Espoo, Finland – Nokia today announced that it has been selected as the sole vendor by Slovenia’s T-2 in a five-year deal to supply equipment from its comprehensive AirScale 5G portfolio. The new deal will see Nokia upgrade T-2’s existing Single RAN radio footprint as well as introduce enhanced 5G new radio (NR) services. The project is expected to deliver ultra-fast, low-latency, and high-capacity 5G connectivity delivering superior coverage to businesses and consumers alike. Nokia will provide equipment from its latest AirScale radio portfolio, all powered by Nokia's energy-efficient ReefShark System-on-Chip technology. This includes 5G RAN, AirScale base stations, and Nokia AirScale radio access products including its Single RAN portfolio for both indoor and outdoor coverage. These solution

Scandinavian Tobacco Group A/S: Transactions in connection with share buy-back programme18.10.2021 09:24:27 CEST | Press release

Company Announcement No. 51/2021 Copenhagen, 18 October 2021 Transactions in connection with share buy-back programme On 10 March 2021, Scandinavian Tobacco Group A/S (“STG”) announced that a share buy-back programme of an aggregated price of up to DKK 600 million was launched with the purpose to adjust the Company’s capital structure and meet obligations relating to the Group’s share-based incentive programme. The buy-back programme is executed in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (the “Market Abuse Regulation”) and Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. The share buy-back programme will end no later than 28 February 2022. The following transactions have been executed from 11 October to 15 October 2021: Number of sharesAverage purchase price, DKKTransaction value, DKKAccumulated, last announcement2,892,365366,515,65211 October 202117,481129.962,271,75912 October 20219,122

KALLELSE TILL EXTRA BOLAGSSTÄMMA I HOYLU AB (PUBL)18.10.2021 08:35:00 CEST | Pressemelding

KALLELSE TILL EXTRA BOLAGSSTÄMMA I HOYLU AB (PUBL) Aktieägarna i Hoylu AB (publ), org. nr 559084-6381 ("Bolaget") kallas härmed till Bolagets extra bolagsstämma måndagen den 22 november 2021, kl. 10.00 hos Eversheds Sutherland Advokatbyrå på Strandvägen 1 i Stockholm. Inregistrering inleds kl. 09.45. INFORMATION MED ANLEDNING AV COVID-19 Med anledning av COVID-19 kommer Bolaget att vidta vissa försiktighetsåtgärder inför extra bolagsstämman. För att minska risken för smittspridning kommer ingen förtäring eller dryck att erbjudas. Styrelsemedlemmar och Bolagets ledning kommer i möjligaste mån att närvara via elektronisk uppkoppling. Aktieägarna har möjlighet att närvara via ombud. DELTAGANDE En aktieägare som vill delta på extra bolagsstämman ska: vara införd i den av Euroclear Sweden AB förda aktieboken senast fredagen den 12 november 2021, ochanmäla sitt deltagande senast tisdagen den 16 november 2021, helst före kl. 16.00. Anmälan att delta på extra bolagsstämman ska ske via e-post t

NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN HOYLU AB (PUBL)18.10.2021 08:35:00 CEST | Press release

N.B. This English text is an unofficial translation of the Swedish original of the notice to attend the extraordinary general meeting in Hoylu AB (publ), and in case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail. NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN HOYLU AB (PUBL) The shareholders of Hoylu AB (publ), reg. no 559084-6381 (the “Company”) are hereby summoned to attend the extraordinary general meeting held at 10:00 (CET) on Monday 22 November 2021 at the premises of Eversheds Sutherland Advokatbyrå located at Strandvägen 1, Stockholm, Sweden. Registration begins at 09:45 (CET). INFORMATION RELATED TO THE CORONA VIRUS To minimise the risk of spreading the corona virus, no food and beverages will be served at the EGM. Participation of board members and company management will be restricted to online where possible. Shareholders who so desire can attend via a representative. NOTIFICATION OF PARTICIPATION ETC. Share

Hoylu AB (publ) carries out a SEK 19.2 million convertible loan notes issue and calls for EGM to resolve on a SEK 0.9 million convertible loan notes issue to board members18.10.2021 08:30:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE. The Board of Directors of Hoylu AB (publ) (“Hoylu” or the “Company”) has, with support of authorization granted by the annual general meeting on 21 May 2021, carried out a directed issue of convertible loan notes corresponding to a value of SEK 19.2 million. Furthermore, the Company’s shareholder Fougner Invest AS hasproposed that the Company’s extraordinary general meeting resolves on a directed issue of convertible loan notes of SEK 0.9 million towards COO Truls Baklid and CFO Karl Wiersholm and the board members Johan Lindqvist and Hans Othar Blix.Noticeconvening the extraord

Reminder: Program for the publication of Yara International ASA third quarter results 202118.10.2021 08:00:00 CEST | Press release

The Yara International ASA third quarter 2021 results will be published on Wednesday20 October 2021at08:00 CEST. An on-line presentation will be held at 12:00 CEST, hosted by Yara President and CEO Svein Tore Holsether. The presentation will be held in English. The report, presentation and webcast will be available at the above mentioned times at: yara.com/investor-relations/latest-quarterly-report/ There will also be a conference call at 13:00 CEST the same day with an opportunity to ask questions to Yara’s management. Please use this link for online registration for the conference call: http://emea.directeventreg.com/registration/5886579 Participants must register in advance of the conference using the link provided. Upon registering, each participant will be provided with participant dial-in numbers, Direct Event passcode and unique registrant ID.In the 10 minutes prior to call start time, participants will need to use the conference access information provided in the email received

PRESS RELEASE: Bigben finalizes the acquisition of Metronic18.10.2021 07:45:00 CEST | Press release

Press release Lesquin, 18 October 2021, 8:00 hrs Bigben finalizes the acquisition of Metronic (Home Digital Lifebusiness unit of HF Company) Bigben announces the completion of the acquisition of METRONIC within its Audio/Telco Division. METRONIC is the European leader in image processing with a strong position in connected audio-video. Founded in 1987 by Yves Bouget, METRONIC, a recognized player in its sector, designs and distributes innovative products for broadcasting and receiving images in the home (TV and audio accessories, amplifiers, decoders, connectors, headsets, speakers, etc.) as well as telephone accessories and audio products. METRONIC brand products are distributed through a variety of channels, notably through the largest national retailers in each country. METRONIC has offices in France (Tours), Spain and Italy, and employs approximately 90 people. Including its subsidiaries, METRONIC posted sales of 24 M€ and EBITDA of 1.9 M€ as of December 31, 2020. Many synergies be