GlobeNewswire

Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer

Share
  • Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival (OS) and progression-free survival (PFS) benefit in the first-line treatment of people with advanced, non-squamous non-small cell lung cancer

Basel, 26 July 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC. This decision is based on results from the Phase III IMpower130 study, which demonstrated that the Tecentriq combination therapy helped people live significantly longer, compared with chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64–0.98; p=0.033) in the intention-to-treat (ITT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001) in the ITT-WT population.1 The safety profile of the Tecentriq combination therapy was consistent with that observed in previous studies.

“We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based lung cancer combination for people living with non-squamous non-small cell lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a complex disease that requires a range of treatment options. We are now one step closer to providing another important alternative for this difficult-to-treat form of cancer”.

Despite recent advances in the treatment of NSCLC, there is still a need for new options to support a tailored approach to treatment of this complex disease. 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

Based on the CHMP positive opinion, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future.


About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 723 people who were randomised (2:1) to receive:

  • Tecentriq plus carboplatin and nab-paclitaxel (Arm A), or
  • Carboplatin and nab-paclitaxel (Arm B, control arm)

During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until disease progression.

The co-primary endpoints were: 

  • PFS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in the ITT-WT population
  • OS in the ITT-WT population

A summary of the ITT data from the IMpower130 study that support this recommendation is included below:1

  • Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (median OS=18.6 versus 13.9 months; HR=0.79; 95% CI: 0.64–0.98; p=0.033).
  • Tecentriq in combination with chemotherapy significantly reduced the risk of disease worsening or death (PFS) by 36% compared with chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001)
  • Tecentriq in combination with chemotherapy shrank tumours (overall response rate [ORR]) in 49.2% of people (95% CI: 44.49–53.96) compared with 31.9% of people (95% CI: 25.84–38.36) on chemotherapy alone.
  • The median duration of response (DoR) for people receiving Tecentriq in combination with chemotherapy was 8.4 months (95%, CI: 6.9–11.8) compared with 6.1 months (95% CI: 5.5–7.9) for people on chemotherapy alone.
  • Grade 3-4 treatment-related adverse events (AEs) were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared to 60.3% of people receiving chemotherapy alone. The most common Grade 3 - 4 AEs in people receiving Tecentriq plus chemotherapy were an abnormal low count of a certain type of white blood cell (neutropenia, 32.1%), a decrease in red blood cells (anaemia, 29.2%) and decreased neutrophil count (12.1%).

About NSCLC
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 small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 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.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] Capuzzo F et al. IMpower130: Progression-free survival (PFS) and safety analysis from a randomised phase 3 study of carboplatin + nab-paclitaxel (CnP) with or without atezolizumab (atezo) as first-line (1L) therapy in advanced non-squamous NSCLC. Presented at: European Society for Medical Oncology’s (ESMO) 2018 Conference on 22 October 2018, Munich, Germany. Abstract #LBA53.
[2] 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 July 2019.
[3] 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 July 2019.

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

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

NAXS Delårsrapport januari – september 201918.10.2019 17:45:00 CESTPressemelding

Nio månader 2019 Resultat efter skatt uppgick till 26,4 (22,2) MSEK. Resultatet per aktie uppgick till 2,29 (1,70) SEK. Substansvärdet uppgick till 717 MSEK (SEK 64,16 per aktie) per den 30 september 2019, jämfört med 736 MSEK (SEK 61,81 per aktie) per den 31 december 2018. De omfattande aktieåterköpen under delårsperioden samt betalning av utdelningen för 2018 var de två viktigaste orsakerna till det minskade substansvärdet. Nettokassan uppgick till 194 MSEK (17,40 SEK per aktie) per den 30 september 2019, jämfört med 261 MSEK (21,94 SEK per aktie) per den 31 december 2018. Årsstämman 2019 beslutade att lämna en utdelning om 2,78 SEK per aktie. Tredje kvartalet 2019 Resultat efter skatt uppgick till 11,7 (10,6) MSEK. Resultatet efter skatt per aktie uppgick till 1,05 (0,86) SEK. VD-kommentar NAXS hade en fortsatt stabil utveckling under det tredje kvartalet med en tillväxt i substanse/aktie om 3% under kvartalet och 7,4% över en 12-månaders period, inklusive lämnad utdelning. NAXS har

Interim Report January-September 201918.10.2019 17:45:00 CESTPress release

Nine months 2019 Net profit/loss for the period amounted to MSEK 26.4 (22.2). Earnings per share amounted to SEK 2.29 (1.70). Net asset value amounted to MSEK 717 (SEK 64.16 per share) at September 30, 2019, compared to MSEK 736 (SEK 61.81 per share) at year-end 2018. The fact that the total net asset value decreased, while the net asset value per share increased is due to the shares repurchases made during the period. Net cash amounted to MSEK 194 (SEK 17.40 per share) at September 30, 2019, compared to MSEK 261 (SEK 21.94 per share) at year-end 2018. The 2019 Annual General Meeting resolved that a dividend of 2.78 SEK per share to the shareholders for FY 2018. Third quarter 2019 Net profit/loss for the quarter amounted to MSEK 11.7 (10.6). Earnings per share amounted to SEK 1.05 (0.86). Comments by the CEO NAXS delivered a steady performance during the third quarter of 2019, with the NAV/share growing by 3% during the quarter and by 7.4% over 12 months, including the dividend paid. N

DNO ASA: Mandatory Notification of Trade18.10.2019 16:47:00 CESTPress release

Oslo, 18 October 2019 - DNO ASA, the Norwegian oil and gas operator, has today purchased 1,200,000 own shares at an average price of NOK 12.4482 per share. Following this transaction, DNO holds 78,800,000 own shares. -- For further information, please contact: Media: media@dno.no Investors: investor.relations@dno.no -- DNO ASA is a Norwegian oil and gas operator focused on the Middle East and the North Sea. Founded in 1971 and listed on the Oslo Stock Exchange, the Company holds stakes in onshore and offshore licenses at various stages of exploration, development and production in the Kurdistan region of Iraq, Norway, the United Kingdom, Netherlands, Ireland and Yemen. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

PCI Biotech: Mandatory notification regarding trade of shares18.10.2019 14:59:00 CESTPress release

Stocken Invest AS, a wholly owned company by Lars Viksmoen, has on 18 October 2019 transferred 12,966 shares in PCI Biotech Holding ASA (“PCI Biotech”) to Lars Viksmoen, board member of PCI Biotech, at an average price of NOK 26.80 per share. After the transaction, Lars Viksmoen holds 12,966 shares in PCI Biotech and Stocken Invest AS holds 0 shares in PCI Biotech. This information is subject to the disclosure requirements pursuant to section 4-2 of the Norwegian Securities Trading Act.

Announcement of the Management Board of joint stock company “Olainfarm”18.10.2019 14:23:00 CESTPress release

The joint stock company “Olainfarm” has received draft decisions prepared by the initiators of the November 1, 2019 Extraordinary General Meeting of Shareholders – limited liability company “OLMAFARM” and Andrejs Saveljevs who is authorized representative of Nika Saveljeva, which include, inter alia, a list of candidates for the Council and Auditing committee of joints stock company “Olainfarm”. The requirements laid down in the laws and regulations in force in Republic of Latvia and in related documents determines the specific requirements to be complied with by capital companies listed in regulated market regarding their management and disclosure of information. Legislation of the Republic of Latvia (including the Financial Instrument Market Law) sets requirements for capital companies, and the European Union and the OECD (Organization for Economic Co-operation and Development) set out recommendations for the corporate governance of the capital companies. Nasdaq Riga, AS has develope

Nordic American Tankers Limited (NYSE:NAT) Announces the date for its 2019 Annual General Meeting of Shareholders (AGM)18.10.2019 13:32:00 CESTPress release

Hamilton, Bermuda, October 18, 2019. Nordic American Tankers Limited today announced that its Board of Directors has scheduled the 2019 AGM, to be held on November 20, 2019 at 10:00 a.m., local time, at the LOM Building,27 Reid Street, Hamilton HM 11 Bermuda. The Board has set a record date of October 8, 2019 for the determination of the NAT shareholders entitled to receive notice of and to vote at the AGM or any adjournment thereof. The Notice of the Meeting and Proxy Statement will be furnished to the Securities and Exchange Commission (SEC) on October 18, 2019. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals,