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

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 Study(7)
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/Meta
staticBreastCancer.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
(12)Tell Her 2 http://tellher2.ca/her2/ (Accessed March 19, 2013) 
Jeanelle Frampton / Shaday Livingston jframpton@environicspr.com 
/slivingston@environicspr.com 416-969-2670 / 416-969-2759 
Laura Pagnotta Manager, Corporate Relations Roche Canada 905-542-5853 
laura.pagnotta@roche.com 
SOURCE: Roche Canada 
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-0- Apr/23/2013 12:15 GMT