Health Canada approves Tecentriq® (atezolizumab), first new treatment in 20 years for aggressive form of lung cancer(1)
Data show Tecentriq in combination with carboplatin and etoposide helped patients with extensive-stage small cell lung cancer live longer, with a 30% reduction in the risk of death2
MISSISSAUGA, ON, Aug. 13, 2019 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved Tecentriq® (atezolizumab) in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC),3 representing the first new treatment for the disease in more than two decades.4 Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line small cell lung cancer.
Lung cancer is the most commonly diagnosed cancer in Canada, with an average of 78 Canadians diagnosed every day.5 It is also the leading cause of death from cancer.6 SCLC is the most aggressive form of lung cancer, characterized by fast growing tumours and early metastasis, and accounts for approximately 15% of all lung cancer cases in Canada – the equivalent of 4,300 new patients each year.7 Of all new SCLC cases, two-thirds are diagnosed as extensive-stage.8 The prognosis for patients with ES-SCLC has historically been extremely bleak, with an estimated five-year survival rate of 3%.9
"Atezolizumab in combination with chemotherapy provides a clinically meaningful improvement in overall survival when compared to chemotherapy alone, while most importantly improving quality of life for patients. This is an important milestone, since previously, there were limited treatments available," says Dr. Rosalyn Juergens, Associate Professor of Oncology at McMaster University. "The Health Canada approval of the Tecentriq regimen represents a new option and we are optimistic about the role it can play for this challenging to treat patient population in the future."
This approval is based on results from the Phase III IMpower133 study, which is the first Phase III study with an immunotherapy-based combination to show improvement in overall survival and progression-free survival in first-line treatment of ES-SCLC. The study showed that Tecentriq in combination with carboplatin and etoposide helped people live longer, compared with chemotherapy alone (median overall survival [OS] was 12.3 versus 10.3 months; hazard ratio [HR] was 0.70; 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population, corresponding to an estimated 30% reduction in the risk of death. The 1-year overall survival rate was approximately 13% higher in the atezolizumab group than in the placebo group (51.7% vs. 38.2%). Median progression free survival [PFS] was 5.2 months versus 4.3 months; HR was 0.77; 95% CI:0.62-0.96; p=0.017.10
"The unmet need in small cell lung cancer is very high as the majority of patients are diagnosed at a late stage," says Shem Singh, Executive Director Lung Cancer Canada. "New treatment options are needed and the approval of atezolizumab provides a new tool for Canadians living with small cell lung cancer to manage the disease and spend more time with their families."
About the IMpower133 study11
IMpower133 is a global randomized, multicentre, double-blind, placebo-controlled Phase I/III study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and etoposide versus carboplatin and etoposide alone in adults with chemotherapy-naïve ES-SCLC. A total of 403 people were enrolled in the study.
The co-primary endpoints were PFS and OS in the ITT population.
The safety profile of the Tecentriq in combination with carboplatin and etoposide was consistent with the known risks of the individual treatment components. The most common adverse reactions in people receiving Tecentriq in combination with carboplatin and etoposide were: anemia (43.4%), nausea (37.9%), decreased appetite (27.3%), fatigue (27.3%), vomiting (19.7%), thrombocytopenia (16.7%), platelet count decreased (12.6%), hypothyroidism (10.1%), dyspnea (10.1%), and pyrexia (10.1%).
The IMpower133 regimen is now included as the preferred treatment option for previously untreated ES-SCLC in the 2019 NCCN Clinical Practice Guidelines in Oncology for SCLC.12
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells.13 This blocks the interactions of PD-L1 with other cell-surface receptors which regulate the activation or suppression of T cells, a type of white blood cell that protects the body from infection and disease, including cancer.14, 15
Currently, Roche has twelve Phase III lung cancer studies evaluating Tecentriq as monotherapy or in combination with other medicines.
In Canada, Tecentriq is approved in combination with bevacizumab and paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous NSCLC. Tecentriq is also approved for the second-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving Tecentriq. In addition, under the Notice of Compliance with conditions (NOC/c) policy, Tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.
About Roche in Lung Cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with the disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. In Canada, we currently have four approved medicines to treat certain kinds of lung cancer and a range of additional medicines under development to target the most common genetic drivers of lung cancer or to boost the immune system's ability to combat the disease.
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 personalized 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 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.
Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is 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.
All trade-marks mentioned are the property of their respective owners.
© Copyright 2019; Hoffmann-La Roche Limited
|1||Horn, L. et al. (2018) 'First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer', The New England Journal of Medicine, 379: 2220-2229. Retrieved from:https://www.nejm.org/doi/full/10.1056/NEJMoa1809064|
|2||Tecentriq (atezolizumab) Canadian Product Monograph|
|3||Tecentriq (atezolizumab) Canadian Product Monograph|
|4||Horn, L. et al. (2018) 'First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer', The New England Journal of Medicine, 379: 2220-2229. Retrieved from:https://www.nejm.org/doi/full/10.1056/NEJMoa1809064|
|5||Canadian Cancer Society. Lung Cancer Statistics. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on|
|6||Canadian Cancer Society. Lung Cancer Statistics. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on|
|7||Canadian Cancer Society. Cancerous tumours of the lung. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on|
|8||The American Cancer Society. Small Cell Lung Cancer Stages. Retrieved from: https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/staging.html|
|9||The American Cancer Society. Small Cell Lung Cancer Survival Rates. Retrieved from: https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/survival-rates.html|
|10||Tecentriq (atezolizumab) Canadian Product Monograph|
|11||Tecentriq (atezolizumab) Canadian Product Monograph|
|12||NCCN Clinical Practice Guidelines in Oncology: SCLC v1.2019. Retrieved from: https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf|
|13||Tecentriq (atezolizumab) Canadian Product Monograph|
|14||National Cancer Institute. T-Lymphocytes. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022044/. Last accessed February 5, 2018|
|15||Jin, H.T. et al. Role of PD-1 in regulating T-cell immunity. Current Topics in Microbiology and Immunology. 2011; 350:17-37. Retrieved from:https://www.ncbi.nlm.nih.gov/pubmed/21061197|
SOURCE Roche Canada