Cancer Care Ontario Adds PERJETA®-HERCEPTIN® Combo Pack for Treatment of HER2-Positive Metastatic Breast Cancer to the Provincial Formulary

MISSISSAUGA, ON, Dec. 11, 2013 /CNW/ - People with HER2-positive metastatic breast cancer in Ontario will now be able to access a new treatment option through the New Drug Funding Program (NDFP) of Cancer Care Ontario (CCO).  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 with an ECOG status of 0 or 1, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.¹

"Cancer Care Ontario's addition of the PERJETA-HERCPETIN Combo Pack to the Ontario formulary provides an important option in a HER2-positive metastatic breast cancer patient's fight against the disease," said Mr. Ronnie Miller, president and CEO, Roche Canada. "Roche Canada is committed to continuing to improve breast cancer treatment through innovative research and development, and we are pleased that patients in Ontario continue to have more treatment choices available to them."

In Canada, breast cancer is the most commonly diagnosed cancer in women.²  It accounts for 26 per cent of all cancer cases, making it the second leading cause of death in women.¹ On average, 9,300 women in Ontario are diagnosed with breast cancer every year.³

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.⁴

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

To-date, British Columbia, Ontario and Saskatchewan have funded the PERJETA-HERCEPTIN Combo Pack.

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).^9,11  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, median overall survival had not yet been reached because more than half of the patients receiving the PERJETA combination were still alive.¹¹ 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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References
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¹ Cancer Care Ontario.  https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=291584  (Accessed November 28, 2013)
² Canadian Cancer Society. http://www.cancer.ca/en/cancer-information/cancer-type/breast/statistics/?region=on (Accessed October 29, 2013)
³ Canadian Breast Cancer Foundation.  http://www.cbcf.org/central/AboutBreastCancerMain/AboutBreastCancer/Pages/BreastCancerinCanada.aspx (Accessed November 25, 2013)
⁴ Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed March 19, 2013)
⁵ BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed March 19, 2013)
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 http://tellher2.ca/her2/ (Accessed October 29, 2013)
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 S, et al. Confirmatory overall survival analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled Phase III study with pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive first-line metastatic breast cancer. Poster presented at the 2012 CTRC-AARC San Antonio Breast Cancer Symposium. Abstract # P5-18-26.

SOURCE: Roche Canada

Laura Pagnotta
Manager, Corporate Relations
Roche Canada
905-542-5853
[email protected]