Health Canada approves KADCYLA™ (trastuzumab emtansine) for the treatment of HER2-positive metastatic breast cancer

New personalized medicine helped people in Phase III study live longer, with less toxicityⁱ

MISSISSAUGA, ON, Sept. 12, 2013 /CNW/ - Roche today announced that Health Canada has approved KADCYLA (trastuzumab emtansine or T-DM1), under priority review, as a single agent for the treatment of people with HER2-positive metastatic breast cancer (mBC) who received both prior treatment with HERCEPTIN^® (trastuzumab) and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.ⁱⁱ HER2-positive metastatic breast cancer is a particularly aggressive form of the disease. Women with HER2-positive mBC are at an increased risk of their disease worsening due to the cancer's hard-to-treat nature.ⁱⁱⁱ

KADCYLA is a first in class antibody-drug conjugate (ADC) and is made up of three components, an approved monoclonal antibody known as HERCEPTIN (trastuzumab), a stable linker, and a potent cytotoxic agent known as DM1.  KADCYLA targets cancer cells that overexpress the HER2 receptor and, via two distinct mechanisms, results in cell cycle arrest or death of cancer cells.ⁱⁱ

According to Dr. Sunil Verma, EMILIA study first author and medical oncologist at Sunnybrook's Odette Cancer Centre, KADCYLA represents an important advance in the treatment of HER2-positive metastatic breast cancer.  He states:  "KADCYLA specifically targets HER2-positive cancer cells, destroying them efficiently and effectively while extending progression-free and overall survival.  This targeted approach allows for greater efficacy and lowered toxicity compared with standard treatment."

The Health Canada approval of KADCYLA is based on results from the EMILIA Study, an open-label, international, and randomized Phase III study comparing KADCYLA to lapatinib in combination with XELODA^® (capecitabine), one of the standard treatment options in this setting. EMILIA assessed 991 randomly assigned patients with HER2-positive locally advanced or metastatic breast cancer who had previously been treated with HERCEPTIN and a taxane chemotherapy.

People who received KADCYLA had a median Overall Survival (OS) improvement of 5.8 months (HR=0.682, p=0.0006; median OS 30.9 months versus 25.1 months) than those who received the combination of lapatinib and XELODA. Study findings also showed that people who received KADCYLA had significantly longer Progression Free Survival (PFS) (HR=0.650, p<0.0001; median PFS 9.6 months vs. 6.4 months) with less grade 3 or 4 toxicity.^i,ii

About KADCYLA
KADCYLA combines the known antibody trastuzumab (HERCEPTIN) and the potent cytotoxic agent, DM1, together using a stable linker, which is designed to keep KADCYLA intact until it reaches specific cancer cells to avoid systemic toxicity. The antibody (HERCEPTIN) portion binds to the HER2-positive cancer cells, and is thought to inhibit cell signaling and activate the body's immune system to attack the cancer cells, resulting in cell cycle arrest or cell death. In addition, when KADCYLA is absorbed into those cancer cells, it is designed to destroy them by releasing the cytotoxic agent.

Roche has studied ADC science for more than a decade and has eight different ADCs in Phase 1 or Phase II studies for different types of cancer. KADCYLA is the first ADC resulting from Roche and Genentech's 30 years of HER2 pathway research and this promising approach will help deliver more medicines to fight other cancers in the future. KADCYLA is the third personalized medicine Roche has developed for the treatment of HER2-positive breast cancer, after HERCEPTIN and PERJETA™.

Roche licenses technology for KADCYLA under an agreement with ImmunoGen, Inc.

About Breast Cancer in Canada
Breast Cancer is the most common cancer diagnosis for women in Canada. Accounting for 26 per cent of all cancer cases, it is the second leading cause of death in women. On average, 65 women are diagnosed with breast cancer every day and it claims the lives of 100 Canadian women every week.^iv

Metastatic (also known as advanced, secondary, or stage IV) breast cancer is the spread of cancer cells from the original site where the cancer first formed to other parts of the body. It is associated with increased severity and is largely incurable.^v,vi The median survival for a woman with this form of breast cancer is two years.^vi

Women with HER2-positive breast cancer test positive for a protein called human epidermal growth factor receptor (HER2).^vii 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 tumor growth and poor clinical outcomes.^vii,viii,ix One in twenty-nine Canadian women will lose their life to the disease.^iv

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.	Verma S, et al. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer. N Engl J Med 2012; 367:1783-1791.
2.	KADCYLA Product Monograph.  September XX, 2013.
3.	Mayo Clinic. HER2-positive Breast Cancer. http://www.mayoclinic.com/health/breast-cancer/AN00495 (Accessed March 19, 2013)
4.	Canadian Cancer Society. http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/Breast%20cancer.aspx?sc_lang=en
5.	BC Cancer Agency. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Breast/Management/MetastaticBreastCancer.hm (Accessed March 19, 2013)
6.	Canadian Breast Cancer Network. http://www.cbcn.ca/index.php?pageaction=content.page&id=125&lang=en (Accessed March 19, 2013)
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.	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
9.	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

SOURCE: Roche Canada

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