GlobeNewswire

European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer

Share
  • Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved by the European Medicines Agency for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
  • The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 6 September 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care – an advance that, until now, has been difficult to achieve due to the refractory nature of this disease.”

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95% CI, 0.62–0.96; p=0.017).1 Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

Lung cancer is the leading cause of cancer death worldwide2 and SCLC accounts for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the “extensive stage”, often meaning a poor prognosis.3 SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth, and early development of metastatic disease.3

Currently, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq alone 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, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower133 study

IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC.

The study enrolled 403 people who were randomised equally (1:1) to receive: 

  • Tecentriq in combination with carboplatin and etoposide (Arm A), or
  • Placebo in combination with carboplatin and etoposide (Arm B, control arm)

During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS, as determined by the investigator using RECIST v1.1, and OS in the ITT population.

A summary of the ITT data from the IMpower133 study that support this approval is included below:1

  • Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54-0.91, p=0.0069) in the ITT population.
  • The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95% CI: 0.62–0.96, p=0.017).
  • Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
  • Grade 3–4 treatment-related adverse events occurred in 56.6% of people receiving Tecentriq plus chemotherapy, compared with 56.1% of people receiving chemotherapy alone. The most common adverse reactions (≥20%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).

About SCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.3

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 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:
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 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.

References
[1] Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med 2018;379: 2220–2229
[2] World Health Organization. GLOBOCAN 2018; Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed August 2019.
[3] Paglialunga L et al. Immune checkpoint blockade in small cell lung cancer: is there a light at the end of the tunnel? ESMO Open 2016;1:e000022.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Daniel Grotzky
- Karsten Kleine
- Nathalie Meetz
- Barbara von Schnurbein

Attachment

About GlobeNewswire

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

https://globenewswire.com

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

Mandalay Resources Corporation tillkännager produktions- och försäljningsresultat för fjärde kvartalet och helåret 2019 samt produktions- och kostnadsprognos för 202018.1.2020 13:30:00 CETPressemelding

TORONTO, Jan. 18, 2020 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation (”Mandalay” eller ”bolaget”) (TSX: MND, OTCQB: MNDJF) tillkännagav idag sina produktions- och försäljningsresultat för fjärde kvartalet och helåret 2019. Under fjärde kvartalet 2019 producerade Mandalay en konsoliderad mängd motsvarande 18 594 säljbara uns guldekvivalent och sålde 16 228 uns guldekvivalent. För helåret som slutade den 31 december 2019 producerade Mandalay 76 659 säljbara uns guldekvivalent och sålde 77 043 uns guldekvivalent. Dominic Duffy, President och Chief Executive Officer för Mandalay, kommenterar, ”Mandalays konsoliderade produktion för helåret 2019 motsvarade den reviderade prognosen som tillkännagavs i oktober 2019 för guld, antimon och guldekvivalenta uns. Björkdal fortsatte sin stabila drift under fjärde kvartalet med en produktion på 10 990 uns säljbart guld och 51 498 uns säljbart guld för helåret, en ungefärlig ökning på 12 % sedan samma period året innan. Vid Costerfield var result

Conditions for Riksbank Bid Procedures Sek Bonds17.1.2020 16:20:00 CETPress release

Sveriges Riksbank Bid procedure details Government Bonds, 2020-01-23 Maturity date Loan ISIN code Coupon Volume, SEK million 2025-05-12 1058 SE0005676608 2.50 % 500 +/- 250 2028-05-12 1060 SE0009496367 0.75 % 500 +/- 250 Settlement date 2020-01-27 Bids have to be entered by 10.00 on JAN 23, 2020 Highest permitted bid volume: 500 SEK million in issue SGB 1058 and 500 SEK million in issue SGB 1060 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CET) ON JAN 23, 2020. For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se

The Board of Directors of Cramo Plc supplements its statement regarding the recommended voluntary public cash tender offer by Boels Topholding B.V. due to the increase in the Offer Price17.1.2020 15:30:00 CETPress release

Cramo Plc Stock exchange release 17 January 2020 at 4.30 pm (EET) The Board of Directors of Cramo Plc supplements its statement regarding the recommended voluntary public cash tender offer by Boels Topholding B.V. due to the increase in the Offer Price NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO CANADA, JAPAN, AUSTRALIA, SOUTH AFRICA OR HONG KONG, OR IN ANY OTHER JURISDICTION IN WHICH THE TENDER OFFER WOULD BE PROHIBITED BY APPLICABLE LAW. FOR FURTHER INFORMATION, SEE SECTION "IMPORTANT LEGAL INFORMATION" BELOW. On 11 November 2019, Boels Topholding B.V. (the "Offeror" or "Boels") announced that it will make a recommended voluntary public cash tender offer to acquire all of the issued and outstanding shares in Cramo Plc ("Cramo") that are not held by Cramo or any of its subsidiaries (the "Shares") (the "Tender Offer"). The Board of Directors of Cramo (the "Cramo Board") has on 20 November 2019 issued a statement (the "Statement"

CrossAmerica Partners to Announce Year-End/Fourth Quarter 2019 Earnings Results on February 2517.1.2020 12:45:00 CETPress release

Allentown, Jan. 17, 2020 (GLOBE NEWSWIRE) -- CrossAmerica Partners to Announce Year-End/Fourth Quarter 2019 Earnings Results on February 25 ALLENTOWN, PA, January 17, 2020 – CrossAmerica Partners LP (NYSE: CAPL) today announced that it will release its year-end/fourth quarter 2019 results after the market closes on Tuesday, February 25, 2020. In conjunction with the news release, management will host a conference call on Wednesday, February 26, at 9:00 a.m. Eastern Time. The conference call numbers are 877-420-2982 or 847-619-6129 and the passcode for both is 5577665#. A live audio webcast of the conference call and the related earnings materials, including reconciliations of any non-GAAP financial measures to GAAP financial measures and any other applicable disclosures, will be available on that same day on the investor section of the CrossAmerica website (www.crossamericapartners.com). To listen to the audio webcast, go to https://caplp.gcs-web.com/webcasts-presentations. After the l

Volta Finance Limited - Update Statement regarding AGM voting17.1.2020 11:38:00 CETPress release

17 January 2020 Volta Finance Limited (VTA / VTAS) Update Statement regarding AGM voting Information disclosed in accordance with provision 1.D.4 of the 2018 UK Code of Corporate Governance and principle 5.2.4 of the 2019 AIC Code of Corporate Governance. Volta Finance Limited (the “Company”) announced “Results of the Thirteenth Annual General Meeting” on 6 December 2019 and noted the votes against the resolutions to approve the re-election of the directors, Graham Harrison, Stephen Le Page, Paul Meader, Atosa Moini and Paul Varotsis, contained in resolutions 4 to 8 inclusively. The votes against each resolution equated to 37.05% of the total voted by proxy. The Board, through the Company’s corporate broker, has sought to engage with the dissenting shareholders to understand their concerns. Unfortunately, despite multiple efforts, the Board and its adviser have been unsuccessful to date in gaining any response. The Board invites the dissenting shareholders to engage, either directly th

14 nya butiker – stark tillväxt i Elon Ljud & Bild17.1.2020 10:00:00 CETPressemelding

Under januari har 14 nya butiker anslutit sig till hemelektronikkedjan Elon Ljud & Bild. Kedjan består nu av över 100 butiker runt om i Sverige. ”Vi ser med stor tillförsikt och glädje att vi attraherar och tillför Elon Ljud & Bild nya lokala aktörer till kedjan”, säger Anneli Sjöstedt, VD på Electra. I november 2019 bytte närmare 100 Audio Video-butiker varumärke och bildade Elon Ljud & Bild. Nu vill fler butiker ansluta sig till hemelektronikkedjan. Vid årsskiftet tecknade 14 nya butiker, spridda över hela landet, avtal med Elon Ljud & Bild. De nya medlemsbutikerna kommer från konkurrerande kedjor eller är befintliga Elon butiker som utvidgar sitt koncept med Elon Ljud & Bild. Butikerna blir på så sätt en komplett leverantör av hemelektronik och vitvaror på sina lokala orter. - Vårt koncept ger kunden full handlingsfrihet utifrån sin egen situation och sina behov, vilket vi vet kommer att vara helt avgörande för en positiv köpupplevelse och långsiktig kundnöjdhet. Det känns som en na