Health Canada approves Tecentriq® in combination with chemotherapy (nab-paclitaxel) as first immunotherapy treatment for aggressive form of breast cancer(1) Français
New approval provides patients with PD-L1 positive, metastatic triple-negative breast cancer with an additional treatment option that significantly reduced the risk of disease progression by 38% compared with chemotherapy (nab-paclitaxel) alone2
MISSISSAUGA, ON, Sept. 27, 2019 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada under the Notice of Compliance with Conditions (NOC/c) policy has approved Tecentriq® (atezolizumab) in combination with chemotherapy (nab-paclitaxel) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%, and who have not received prior chemotherapy for metastatic disease.3 Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line TNBC. This approval meets a significant unmet need for TNBC patients.
Health Canada has approved Tecentriq for this indication under provisions made within its Notice of Compliance with Conditions (NOC/c) policy. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers an overall benefit/risk profile which shows improvement over existing therapies.4
Breast cancer is one of the most common cancers among women in Canada and the second most deadly, with an average of 14 Canadian women dying from the disease every day.5 Triple-negative breast cancer makes up 15% of all breast cancers and is the most aggressive form of the disease.6 The prognosis for those with TNBC has typically been poor due to high risk of early relapse and lack of available treatment options beyond chemotherapy.7 In addition, many TNBC cases are diagnosed at a later stage when the tumours have already spread to other parts of the body.8 Women under 50, African-American and Hispanic women and those with the BRCA1 gene mutation are at a higher risk of being diagnosed with this form of the disease.9
"For years, patients with this aggressive form of breast cancer had limited treatment options," says Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Odette Cancer Centre and Assistant Professor, Department of Medicine, University of Toronto. "Tecentriq's Canadian approval in combination with chemotherapy is an important treatment advance, giving patients with PD-L1 positive metastatic TNBC a new option that targets their immune system and ultimately may help extend the time to disease progression."
This approval is based on results from the randomized Phase III IMpassion130 study. The study showed Tecentriq in combination with nab-paclitaxel significantly reduced the risk of disease progression by 38% compared with chemotherapy (nab-paclitaxel) alone (median progression free survival [PFS] was 7.5 versus 5.0 months; hazard ratio [HR] was 0.62; 95% CI: 0.49–0.78; p<0.0001) in the PD-L1 expressing population.10
"It's important for Canadians living with metastatic breast cancer to have access to new treatment options," says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network. "By making the newest treatments available to this high-needs population, patients are given the opportunity to live longer with a good quality of life."
About the IMpassion130 study11
IMpassion130 is a Phase III, multicentre, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (nab-paclitaxel) versus chemotherapy (nab-paclitaxel) alone in adults with unresectable, locally advanced or metastatic TNBC who have not received prior chemotherapy for metastatic disease. A total of 902 people were enrolled in the study.
The co-primary endpoints were PFS in the intention-to-treat (ITT) population and PD-L1 positive population, and overall survival (OS) in the ITT population. Overall survival in the PD-L1 positive population was an additional outcome dependent upon OS results in the ITT population. The final OS analysis in the ITT population is still pending. The estimated HR of OS in patients with PD-L1 expression ≥ 1% at the time of first interim analysis was HR 0.62 (95% CI: 0.45-0.86) but was not formally tested per the pre-defined statistical analysis hierarchy.
The most common adverse reactions in people receiving Tecentriq in combination with nab-paclitaxel were: fatigue (46.7%), nausea (46.0%), peripheral neuropathies (42.5%), diarrhea (32.5%), cough (24.8%), neutropenia (20.8%), decreased appetite (19.9%), vomiting (19.5%), pyrexia (18.8%), arthralgia (17.9%), rash (17.3%), dyspnea (15.9%), back pain (15.3%), hypothyroidism (13.7%), pruritus (13.7%), neutrophil count decreased (12.6%), asthenia (12.4%), urinary tract infection (11.7%), ALT increased (10.4%), and abdominal pain (10.2%).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,14 a type of white blood cell that protects the body from infection and disease, including cancer.15
Currently, Roche has seven Phase III studies evaluating Tecentriq in TNBC, including early and advanced stages of the disease.
In Canada, Tecentriq is approved in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of adults with extensive-stage small cell lung cancer, as well as in combination with bevacizumab and chemotherapy (paclitaxel and carboplatin) for the first-line treatment of people 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 people with 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, Tecentriq is approved conditionally and is indicated for the treatment of patients with metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression with 12 months of neoadjuvant or adjuvant treatment with platinum-containing therapy.
About Roche in Breast Cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with biomarker tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.
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 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
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1 TECENTRIQ (atezolizumab) Product Monograph; August 2019
2 TECENTRIQ (atezolizumab) Product Monograph; August 2019
3 TECENTRIQ (atezolizumab) Product Monograph; August 2019
4 Health Canada. Guidance Document: Notice of Compliance with Conditions (NOC/c). Retrieved from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html
5 Canadian Cancer Society. Breast Cancer Statistics. Retrieved from: https://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on
6 Yao, H. et al. (2017) 'Triple negative breast cancer: is there a treatment on the horizon'? Oncotarget, 8(1), 1913-1924. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/27765921
7 Park JH, Ahn J, Kim S How shall we treat early triple-negative breast cancer (TNBC): from the current standard to upcoming immuno-molecular strategies ESMO Open 2018;3:e000357. doi: 10.1136/esmoopen-2018-000357. Retrieved from: https://esmoopen.bmj.com/content/3/Suppl_1/e000357
8 Canadian Cancer Society. Triple-negative and basal-like breast cancers. Retrieved from: https://www.cancer.ca/en/cancer-information/cancer-type/breast/breast-cancer/cancerous-tumours/triple-negative-breast-cancer/?region=on
9 Medical News Today. Triple-negative breast cancer: Recurrence and survival rates. Retrieved from: https://www.medicalnewstoday.com/articles/324272.php
10 TECENTRIQ (atezolizumab) Product Monograph; August 2019
11 TECENTRIQ (atezolizumab) Product Monograph; August 2019
12 TECENTRIQ (atezolizumab) Product Monograph; August 2019
13 TECENTRIQ (atezolizumab) Product Monograph; August 2019
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15 National Cancer Institute. T-Cells. Retrieved from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/t-cell
SOURCE Hoffmann-La Roche Limited (Roche Canada)
For further information: Bridget Wells, Roche Canada, T: 905-542-5072, E: [email protected]; Diana Robson, Proof Inc., T: 416-969-2815, E: [email protected]
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