NEWS DETAIL

  • Source : PR Newswire
  • Date : 2022-02-04
  • Event type : Approved
  • Companies : Roche

Health Canada Authorizes TECENTRIQ (Atezolizumab) for Canadians With Early Non-Small Cell Lung Cancer (NSCLC)

  • In Canada, lung cancer is the most commonly diagnosed cancer, with estimates that 29,600 Canadians received a diagnosis in 20211


  • Tecentriq® (atezolizumab) is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting

MISSISSAUGA, ON, Feb. 4, 2022 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on January 14, 2022, Health Canada has authorized TECENTRIQ® (atezolizumab) as monotherapy for adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to IIIA* non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TCs).2


TECENTRIQ is a type of cancer immunotherapy treatment.2 Immunotherapy may work by helping the immune system fight the cancerous cells.3 TECENTRIQ works by attaching to a specific protein in your body called Programmed Death Ligand-1, or "PD-L1".2 This protein makes the immune system in your body not work as well. By attaching to the protein, TECENTRIQ helps your immune system to fight your cancer and may reactivate the anti-tumour immune response.3


"The burden of lung cancer is significant and treatment innovation at any stage is important to provide more options," says Shem Singh, Executive Director Lung Cancer Canada. "With this approval, Canadians living with NSCLC now have another option when it comes to managing the disease at an early stage and potentially improving quality of life."


The approval is based on data from the Phase III IMpower010 study comparing TECENTRIQ to best supportive care (BSC) after adjuvant cisplatin-based chemotherapy in patients with completely resected early stage non-small cell lung cancer. In this study, a clinically meaningful improvement in disease-free survival (DFS) in the TECENTRIQ arm was shown compared to the BSC arm in patients with PD-L1 TC ≥ 50% stage II to IIIA.2


TECENTRIQ has nine currently approved indications in Canada, two of which are approved with conditions (NOC/c).2 For the adjuvant treatment of early-stage NSCLC, TECENTRIQ is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.2


"The inclusion of a new treatment for non-small cell lung cancer patients is welcome news," says Peter Glazier, Executive Vice President of the Lung Health Foundation. "For a majority of patients with lung cancer, advances in treatment have been minimal. As an organization focused on addressing the gaps in the prevention, diagnosis, and care of lung disease in Canada, we are very supportive of a new treatment option for Canadians living with lung cancer. "


Lung cancer can be broadly divided into two major types: non-small cell (NSCLC) and small cell lung cancer (SCLC), with about 88 per cent of lung cancer cases in Canada (excluding Quebec) being NSCLC.4 Lung cancer is also classified in stages, as stage I through IV, based on the extent of disease in the body at the time of diagnosis.4


"As a healthcare solutions company, we are excited to provide a new treatment option for Canadians living with non-small cell lung cancer," says Loredana Regep, Vice President, Medical and Regulatory Affairs, Hoffmann-La Roche Limited. "This recent approval gives physicians an additional option for the treatment of early lung cancer after more than a decade with limited treatment advances in this setting."


About the Health Canada Approval


The approval is based on results from an interim analysis of the IMpower010 study that compared TECENTRIQ to best supportive care (BSC) after adjuvant cisplatin-based chemotherapy in patients with completely resected early stage non-small cell lung cancer.2


IMpower010 is a Phase III, open label, multicentre, randomized study evaluating the efficacy and safety of TECENTRIQ for the adjuvant treatment of patients with stage IB (tumors ≥ 4 cm) – IIIA NSCLC (per the Union for International Cancer Control / American Joint Committee on Cancer staging system, 7th edition). People who had complete tumour resection and were eligible to receive cisplatin-based chemotherapy were enrolled. Subsequently, people whose disease had not progressed following completion of cisplatin-based chemotherapy (up to four cycles) were randomized. Patients were randomized in a 1:1 ratio to receive TECENTRIQ (Arm A) or best supportive care (BSC) (Arm B). The primary efficacy outcome measure was DFS as assessed by the investigator.2 DFS was defined as the time from the date of randomization to the date of occurrence of any of the following: first documented recurrence of disease, new primary NSCLC, or death due to any cause, whichever occurred first.2


In the analysis of patients (n = 229) with PD-L1 TC ≥ 50% stage II to IIIA (pre-specified key-secondary endpoint), a clinically meaningful improvement in DFS in the TECENTRIQ arm was shown compared to the BSC arm (hazard ratio [HR]=0.43, 95% CI 0.27-0.68).2


About TECENTRIQ


TECENTRIQ is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which may be expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.2 This protein makes the immune system in your body not work as well. By attaching to the PD-L1 protein, TECENTRIQ may help the immune system fight the cancer.2


TECENTRIQ is a type of cancer immunotherapy treatment.2 Immunotherapy treatments work by helping to strengthen or restore the immune system's ability to fight the cancerous cells.3


About Lung Cancer


Lung cancer is one of the leading causes of cancer death globally.5 In Canada, lung cancer is the most commonly diagnosed cancer and the leading cause of death from cancer in both men and women.1 In 2021, it was estimated that 29,600 Canadians would be diagnosed with lung cancer.1


Lung cancer can be broadly divided into two major types: NSCLC and SCLC, with about 88 per cent of lung cancer cases in Canada (excluding Quebec) being NSCLC.4 In Canada, approximately 50 per cent of patients with NSCLC are diagnosed with stage I to III disease.4 Diagnosing lung cancer early, before it has spread, may improve chances of survival.1


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 personalized healthcare. Roche aims to improve patient access to medical innovations by working with stakeholders across the entire 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, has become an industry leading partner for medical insights, and has collaborated in artificial intelligence (AI) data mining to fuel healthcare insights.


Roche Canada was founded in 1931 and employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.


Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Globally, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI) for twelve consecutive years. Roche Canada is also actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians.


For more information, please visit www.RocheCanada.com or follow us on Twitter @RocheCanada.





SOURCE Roche Canada


For further information: Media Contact: Amy Haddlesey, Roche Canada, 647-283-3406, [email protected]









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1 Canadian Cancer Society, "Lung cancer statistics". Available at: https://cancer.ca/en/cancer-information/cancer-types/lung/statistics. Last Accessed January 14, 2022.



2 Tecentriq Product Monograph, January 14, 2022.



3 Canadian Cancer Society, "Immunotherapy". Available at https://cancer.ca/en/treatments/treatment-types/immunotherapy. Last accessed January 14, 2022.



4 Canadian Cancer Society, "Canadian Cancer Statistics: A 2020 special report on lung cancer". Available at: https://cdn.cancer.ca/-/media/files/cancer-information/resources/publications/2020-canadian-cancer-statistics-special-report/2020-canadian-cancer-statistics-special-report-en.pdf?rev=15c66a0b05f5479e935b48035c70dca3&hash=3D51B0D0FB5C3F7E659F896D66495CE8&_ga=2.216594517.2113955847.1642444815-705743543.1623700008. Accessed January 17, 2022.



5 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
*Per the Union for International Cancer Control/American Joint Committee on Cancer staging system, 7th edition.