Quebec Adds Perjeta (pertuzumab) for Treatment of HER2-Positive Metastatic Breast Cancer to the Province's Hospital Formulary

With the addition of Quebec, over 35 million Canadians now have access to this important treatment option for metastatic breast cancer in Canada1

MISSISSAUGA, ON, July 29, 2015 /CNW/ - People with HER2-positive metastatic breast cancer in Quebec are now able to access a new treatment option through the province's Hospital Formulary. The approved funding allows physicians to use Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the first line treatment of patients with HER2-positive metastatic breast cancer with an ECOG performance status of 0 or 1.2  

The ECOG performance scale is a set of criteria used by physicians to assess how a patient's disease is progressing and how the disease is impacting their daily living abilities in order to identify appropriate treatment options.  Patients with an ECOG status of 0 or 1 are generally active, and able to carry out work either at a pre-disease performance level or of a light, sedentary nature (e.g., light house work, office work).3

"We strongly value our partnerships with the provincial Ministries of Health and congratulate Quebec on this important decision that will benefit hundreds of women living with HER2-positive metastatic breast cancer in the province," said Mr. Ronnie Miller, President and CEO, Roche Canada.  "Our ability to collaborate with payers to help find ways to make our treatments more accessible to patients is a core tenet of our commitment to improving the patient experience in Canada."

In Canada, breast cancer is the most commonly diagnosed cancer in women (excluding non-melanoma skin cancers).4 It accounts for 26 per cent of all new cancer cases, and is the second leading cause of death from cancer in women.4

Metastatic (also known as advanced, secondary or stage IV) breast cancer, the spread of cancer cells from the original site where the cancer first formed to other parts of the body, is associated with increased severity and is largely incurable.5,6

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor 2 (HER2).7  This protein is found in high quantities on the outside of HER2-positive breast cancer cells.  One in five women diagnosed with breast cancer will be HER2-positive and, without treatment, will experience aggressive tumour growth and poor clinical outcomes (i.e., significantly shortened disease-free and overall survival).8,9

In addition to Quebec, Perjeta is also funded in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Newfoundland and Labrador, Prince Edward Island and Yukon.

About Perjeta
Perjeta, in combination with Herceptin and docetaxel chemotherapy, is approved by Health Canada for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.10

The Health Canada approval of Perjeta is largely based on the Phase III CLEOPATRA trial. In the trial, people who received a combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median 6.1 months longer without their cancer getting worse (progression-free survival) compared with the standard of care, Herceptin plus docetaxel chemotherapy alone (median PFS 18.5 versus 12.4 months; HR=0.62; p<0.0001).10,11   Further, the combination of Perjeta, Herceptin and docetaxel chemotherapy significantly extended the lives of people with previously untreated HER2-positive metastatic breast cancer (overall survival) compared to Herceptin, docetaxel chemotherapy and placebo.  The risk of death was reduced by 34 per cent for people on the Perjeta arm of the study, compared to those who received Herceptin and docetaxel chemotherapy alone (HR=0.66; p=0.0008).12

The most common adverse events (AEs) seen in more than 30 per cent of patients treated with Perjeta in combination with Herceptin and docetaxel were diarrhea, alopecia (hair loss), neutropenia (abnormally low count of neutrophils, a type of white blood cell in the blood), nausea, fatigue, rash and peripheral neuropathy (damage to the nerves resulting in numbness, tingling and pain in the hands/feet).  The most common Grade 3/4 AEs occurring in >10 per cent of patients were neutropenia, febrile neutropenia and leukopenia (decrease in the number of white blood cells in the blood). The most common serious AEs were febrile neutropenia, neutropenia and diarrhea.10

At the time of the data analysis, which supported the regulatory submission in Canada, median overall survival had not yet been reached because more than half of the patients were still alive.11 Final overall survival data from the CLEOPATRA trial were presented at the European Society for Medical Oncology (ESMO) Congress in September 2014 and published in the New England Journal of Medicine in February 2015.13 

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. 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.

Disclaimer:  Cautionary statement regarding forward-looking statements
This document may contain certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche's earnings or earnings per share for any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

References

[1]

Statistics Canada, "Population by year, by province and territory," Available online at http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo02a-eng.htm. Last accessed on July 20, 2015

[2]  

Regie de l'assurance maladie (RAMQ), List of Medications - Institutions. Available online at https://www.prod.ramq.gouv.qc.ca/DPI/PO/Commun/PDF/Liste_Med/Liste_Med_Etab/liste_med_etab_2015_07_24_fr.pdf.  Last accessed July 24, 2015

[3]   

National Palliative Care Research Center, ECOG Performance Status. Available online at http://www.npcrc.org/files/news/ECOG_performance_status.pdf. Last accessed on July 21, 2015.

[4]

Canadian Cancer Society. Available online at http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on. Last accessed on July 24, 2015

[5] 

Canadian Breast Cancer Network. About Metastatic Breast Cancer. Available online at http://www.cbcn.ca/index.php?pageaction=content.page&id=8234&lang=en. Last accessed on July 24, 2015

[6]  

BC Cancer Agency. Breast Cancer Management Guidelines: Definition of HER2-Positive. Available online at http://www.bccancer.bc.ca/health-professionals/professional-resources/cancer-management-guidelines/breast/breast#HER2-Positive. Last accessed on July 24, 2015

[7] 

Chia et al. Human Epidermal Growth Factor Receptor 2 Overexpression As a Prognostic Factor in a Large Tissue Microarray Series of Node-Negative Breast Cancers, Journal Of Clinical Oncology. 2008;26:5697-5700

[8]  

Wolff et al. American Society of Clinical Oncology/College of American Pathologists Guideline, Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer, Arch Patho Lab Med 2007;101:18-43

[9] 

Dawood S, et al. Prognosis of Women with Metastatic Breast Cancer by HER2 Status and Trastuzumab Treatment: An Institutional-Based Review. Journal of Clinical Oncology. Available online at http://jco.ascopubs.org/content/28/1/92.full. Last accessed on July 24, 2015 

[10] 

Perjeta Product Monograph.  March 5, 2014.  Hoffmann-La Roche Limited.

[11] 

Baselga J, Cortes J, Sung-Bae K, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012; 366:109-110.

[12] 

Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013; 14:461–471.

[13]

Swain et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N. Engl J Med 2015; 372:724-34. Available online at http://cache1.medsci.cn/webeditor/uploadfile/201502/20150219212117859.pdf. Last accessed on July 24, 2015.

SOURCE Roche Canada

For further information: Naziah Lasi-Tejani, Roche Canada, 905-542-5598, Naziah.Lasi-Tejani@Roche.com


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