Health Canada approves PERJETA™, a new first-in-class targeted therapy for the treatment of HER2-positive metastatic breast cancer(1)

MISSISSAUGA, ON, April 23, 2013 /CNW/ - While awareness and support for breast cancer research is at an all-time high and Canadians "think pink," one-quarter of Canadian women are still not convinced a breast cancer diagnosis may be fatal.² Yet, breast cancer can be a very aggressive disease and claims the lives of 100 Canadian women every week.³

For women with HER2-postive metastatic (or advanced) breast cancer, a particularly aggressive and hard-to-treat form of the disease,⁴ a new first-in-class biological therapy has been approved by Health Canada. PERJETA (pertuzumab), in combination with the current standard of care, HERCEPTIN^® (trastuzumab) and docetaxel chemotherapy, is approved for the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.¹

Women with metastatic HER2-positive breast cancer are at an increased risk of their disease worsening, and ultimately death,^5,6 and therefore need innovative and effective therapies that will give them more time with family and friends.

According to Dr. Christine Brezden-Masley, medical oncologist and Head of the Division of Hematology-Oncology, St. Michael's Hospital and CLEOPATRA clinical trial investigator, PERJETA represents a substantial advancement in the treatment of HER2-positive metastatic breast cancer.  She states:  "since the approval of HERCEPTIN over 10 years ago, we have not had a therapy show such significant benefits in extending survival, and with manageable side effects.  PERJETA is a unique treatment.  It builds on the success of HERCEPTIN and takes it further."

The approval of PERJETA is based on results from the Phase III CLEOPATRA study.  In the study, 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 or PFS) compared to the current standard of care, HERCEPTIN plus docetaxel chemotherapy, alone (median PFS 18.5 months versus 12.4 months; HR=0.62; p<0.0001).^1,7

In fact, 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).  At the time of data analysis, median overall survival had not yet been reached because more than half of the patients receiving the PERJETA combination were still alive.⁸

Betty Power is living with HER2-positive mBC and has been taking PERJETA since August 2012 as part of the CLEOPATRA study.  "Having a new treatment option is a huge step for women with metastatic breast cancer," says Ms. Power.  "Being in the CLEOPATRA trial gave me access to PERJETA and now that Health Canada has approved it, more women could benefit from it."

The combination of PERJETA, HERCEPTIN and chemotherapy is thought to provide a more comprehensive blockade of HER2 signalling pathways.  While HERCEPTIN blocks the "survive and multiply" signals sent by HER2 receptors, PERJETA is designed to prevent the HER2 receptor from pairing or 'dimerizing' with other HER receptors on the surface of cells. This process is believed to play a role in tumour growth and survival.  Binding of PERJETA to HER2 may also signal the body's immune system to destroy the cancer cells.

Leger research revealed nearly half of Canadian women did not believe women with advanced breast cancer in Canada have all the treatment options they need.² This sentiment is shared by patient groups like Rethink Breast Cancer, a breast cancer charity dedicated to boldly and creatively raising awareness of the disease, and who are committed to ensuring all breast cancer patients in Canada receive the best treatments available.

"Until there are no women dying from breast cancer, more treatments are needed," says MJ DeCoteau, Executive Director, Rethink Breast Cancer.  "It is so important that new, effective treatments like PERJETA are quickly available for all women with HER2-positive metastatic breast cancer, so they receive the best defence against their disease."

The Canadian Breast Cancer Network (CBCN), a national network of organizations and individuals committed to the best quality of life for all Canadians affected by the disease, agrees. "HER2-positive metastatic breast cancer is an aggressive disease that requires aggressive action," says Cathy Ammendolea, Board Chair at CBCN and breast cancer survivor.  "We're pleased Canadian women will have a new option that has been shown to prolong a woman's life, while keeping the disease from advancing."

About PERJETA
PERJETA is designed specifically to prevent the HER2 receptor from pairing (or 'dimerizing') with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of PERJETA to HER2 may also signal the body's immune system to destroy the cancer cells. The mechanisms of action of PERJETA and HERCEPTIN are believed to complement each other, as both bind to the HER2 receptor, but to different regions. The combination of PERJETA, HERCEPTIN and chemotherapy is thought to provide a more comprehensive blockade of HER signalling pathways.

About the CLEOPATRA Study⁷
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, phase III, randomized, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of PERJETA combined with HERCEPTIN and docetaxel chemotherapy compared to HERCEPTIN and docetaxel chemotherapy plus placebo in 808 people with previously untreated HER2-positive mBC or where disease had returned after prior therapy in the adjuvant (after surgery) or neo-adjuvant (before surgery) setting.

About Breast Cancer in Canada
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.³ On average, 62 women are diagnosed with breast cancer every day.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.^9,10  The median survival for a woman with this form of breast cancer is two years.¹⁰

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor (HER2).⁵ 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.^5,6,11 Approximately 5,000 women in Canada are living with this disease.¹²

About HERCEPTIN
HERCEPTIN (trastuzumab) is a humanized monoclonal antibody, designed to target and block the function of HER2. The mode of action of HERCEPTIN is unique in that it activates the body's immune system and suppresses HER2 signaling to target and destroy the tumour. HERCEPTIN has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, HERCEPTIN has been shown to improve overall survival, response rates and disease-free survival while maintaining quality of life in women with HER2-positive breast cancer. Since 1998, HERCEPTIN has been used to treat more than 1.2 million people with HER2-positive breast cancer worldwide.

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 personalised 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.

References
____________________________
¹ PERJETA™ Product Monograph.  April 12, 2013.  Hoffmann-La Roche Limited.
² Leger Marketing survey of 1,501 Canadians between March 4 - 6, 2013, with a margin of error of +/- 2.5%, 19 times out of 20.
³ Canadian Cancer Society. http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/Breast%20cancer.aspx?sc_lang=en (Accessed March 19)
⁴ Mayo Clinic. HER2-positive Breast Cancer. http://www.mayoclinic.com/health/breast-cancer/AN00495 (Accessed March 19, 2013)
⁵ 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
⁶ 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
⁷ 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.
⁸ 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.
⁹ Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed March 19, 2013)
¹⁰ BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed March 19, 2013)
¹¹ 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
¹²Tell Her 2 http://tellher2.ca/her2/ (Accessed March 19, 2013)

SOURCE: Roche Canada

Jeanelle Frampton / Shaday Livingston
[email protected] / [email protected]
416-969-2670 / 416-969-2759

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