Swissmedic approves Roche drug Perjeta for patients with breast cancer

Basel, 15 August 2012

New personalised drug confers longer progression-free survival on patients with previously untreated HER2-positive metastatic breast cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Swissmedic (Swiss Agency for Therapeutic Products) has approved Perjeta in Switzerland.

Perjeta is indicated in combination with Herceptin and docetaxel for the treatment of patients with HER2 positive metastatic or locally recurrent surgically unresectable breast cancer who have not previously received chemotherapy for their metastatic disease.1

Approval is based on the results of the Phase IIII study CLEOPATRA. This study showed that patients receiving combination therapy with Perjeta lived an average 6 months longer without their cancer worsening (progression-free survival) than those treated with Herceptin and chemotherapy alone.2 This represents the biggest advance in the treatment of this form of aggressive breast cancer since the introduction of Herceptin 10 years ago. The combination of Perjeta, Herceptin and chemotherapy is the only treatment regimen to have demonstrated significant improvement of progression-free survival compared to Herceptin plus chemotherapy in patients with previously untreated HER2 positive metastatic breast cancer (mBC).2 Patients receiving combination treatment with Perjeta also had a significantly reduced risk of death.

“Over 5’388 Swiss women develop breast cancer every year.3 Thanks to Herceptin and chemotherapy many patients with HER2 positive metastatic breast cancer are surviving for two years without disease progression but close on one half still relapse within 12 months of first-line treatment.4,5 Perjeta offers such women a new and very effective treatment option. Perjeta is the result of decades-long research at Roche,” says Titus Gylvin, Medical Director, Roche Pharma (Switzerland) Ltd.

About Perjeta (pertuzumab)

Perjeta is a humanised monoclonal antibody being studied in the early and advanced stages of HER2 positive breast cancer and advanced HER2 positive stomach cancer. As an HER2 dimerisation inhibitor (HDI), pertuzumab is the first investigational medicine developed to specifically prevent the HER2 receptor from dimerising (pairing) with other HER receptors (EGFR/HER1, HER3 and HER4). HER dimerisation is believe to play an important role in the growth and formation of several different cancer types. By preventing receptor binding, pertuzumab blocks cell signalling, which may ultimately lead to inhibition of cancer cell growth or to the death of the cancer cell. Binding of Perjeta to HER2 may also target cancer cells for destruction by the body’s immune system.

The mechanisms of action of pertuzumab and Herceptin are believed to complement each other as both bind to the HER2 receptor but on different regions. The combination of Perjeta with Herceptin and chemotherapy is thought to achieve a more comprehensive blockade of HER signalling pathways.

Roche has also submitted a marketing licence application to the European Medicines Agency (EMA) for Perjeta in the treatment of patients with previously untreated HER2 positive mBC. This application is still being considered by the EMA.

About the CLEOPATRA study2

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind, placebo-controlled study. It evaluated the efficacy and safety profile of Perjeta combined with Herceptin and docetaxel chemotherapy compared to Herceptin and chemotherapy plus placebo in 808 patients with previously untreated HER2-positive mBC or with HER2-positive mBC recurring after prior therapy in the adjuvant or neo-adjuvant setting. The study showed that the risk of death in patients treated with Perjeta in combination with Herceptin and chemotherapy compared to those treated with placebo and Herceptin plus chemotherapy was reduced by 36 percent (hazard ratio 0.64; p=0.0053). The study demonstrated that median PFS (progression-free survival) in patients treated with Perjeta compared to those treated with Herceptin and chemotherapy plus placebo was extended by 6.1 months (median PFS 18.5 vs 12.4 months; p<0.001).

In the CLEOPATRA study, the most commonly observed adverse reactions (rate greater than 30 percent) seen with Perjeta in combination with Herceptin and docetaxel were diarrhea, hair loss, low white blood cell count, nausea, fatigue and rash. The most common Grade 3–4 adverse reactions (rate greater than 2 percent) were low white blood cell count (with or without fever), decrease in a certain type of white blood cell, diarrhea, peripheral neuropathy (numbness, tingling or burning in the arms or legs), decrease in red blood cell count, weakness and fatigue.

About breast cancer

Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women die annually of the disease.6 In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as “HER2 positivity” and affects approximately 15–20 percent of women with breast cancer.7 HER2-positive cancer is a particularly aggressive form of breast cancer.8

About Herceptin

Herceptin (trastuzumab) is a humanised monoclonal antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when overexpressed. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 signalling 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 response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 1.2 million women 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, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer 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 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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References
1 Swiss data sheet compendium: www.kompendium.ch
2 Baselga J et al. Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer. N Engl J Med 2012;366(2):109-19.
3 NICER, May 2012, http://www.nicer.org/default.aspx?NavigationID=42.
4 Slamon DJ et al. N Engl J Med 2001;344(11):783-92.
5 Marty M et al. J Clin Oncol 2005;23:4265-74.
6 Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr.
7 Wolff AC 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 Pathol Lab Med 2007;131(1):18-43.
8 Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011;365:1273-83.