Prince Edward Island Adds PERJETA®-HERCEPTIN® Combo Pack for Treatment of HER2-Positive Metastatic Breast Cancer to the Provincial Formulary

P.E.I. residents now join nearly 27 Million Canadians across Nine Provinces who have access to this important treatment option for metastatic breast cancer in Canada1

MISSISSAUGA, ON, April 21, 2015 /CNW/ - People with HER2-positive metastatic breast cancer in Prince Edward Island (P.E.I.) will now be able to access a new treatment option through the P.E.I. Pharmacare Formulary.   Pertuzumab (PERJETA®) and trastuzumab (HERCEPTIN®) have been approved for use in combination with a taxane for the treatment of patients with HER2 positive unresectable locally recurrent or metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease or who have not relapsed within six months of receiving trastuzumab in the adjuvant setting.2

"We are pleased to hear about the investment made by the Premier's Office into the P.E.I. Pharmacare Formulary and the province's decision to make the PERJETA-HERCEPTIN Combo Pack available to HER2-positive metastatic breast patients," said Mr. Ronnie Miller, president and CEO, Roche Canada. "As a leader in oncology, Roche is committed to not only advancing science through our research, but also collaborating with key stakeholders within the healthcare system to help bring innovative treatments to patients who need it most."

In Canada, breast cancer is the most commonly diagnosed cancer in women.3  It accounts for 26 per cent of all cancer cases, making it the second leading cause of death in women.2  

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.4,5  The median survival for a woman with this form of breast cancer is two years.5

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor (HER2).6  This protein is found in high quantities on the outside of HER2-positive breast cancer cells.  HER2-positive breast cancer represents approximately 10 to 20 per cent of human cancers, and without treatment, it is associated with aggressive tumour growth and poor clinical outcomes. 5,7,8 Approximately 5,000 women in Canada are living with this disease.9

The PERJETA-HERCEPTIN Combo Pack is also funded in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Newfoundland and Labrador, and Yukon.  Funding for PERJETA continues to be under review in Quebec.

About PERJETA
PERJETA (pertuzumab), in combination with the current standard of care, HERCEPTIN (trastuzumab) 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  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 receiving the PERJETA combination were still alive.11 Final overall survival data from the CLEOPATRA trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2014.  The combination of PERJETA, HERCEPTIN and chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.

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.

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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
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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 April 10, 2015
2     Prince Edward Island Premier's Office, "New $1.5 million investment will provide Islanders with access to 18 new medications," Available at http://www.gov.pe.ca/newsroom/index.php3?number=news&lang=E&newsnumber=10163. Last Accessed on April 10, 2015
3     Canadian Cancer Society. Available online at http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on. Last accessed on April 9, 2014
    Canadian Breast Cancer Network. Available online at http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en Last accessed on April 9, 2014
5     BC Cancer Agency. Available online at http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm Last accessed on April 9, 2014
6     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
7     Ross et al. The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine, The Oncologist. 2009;14:320-368
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     Tell Her 2. Available online at http://tellher2.ca/her2/.  Last accessed on April 9, 2014
10   PERJETA® Product Monograph.  April 12, 2013.  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.

SOURCE Roche Canada

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


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