Roche’s Kadcyla medicine approved in Switzerland in the treatment of a particularly aggressive form of breast cancer

Basel, 07 May 2013

First approval in Europe – Kadcyla is a drug that delivers chemotherapy directly to the tumour cell, resulting in fewer adverse events compared to standard treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Swiss drug regulatory and supervisory authority (Swissmedic) has approved Kadcyla, Roche’s new medicine.

Kadcyla is the first approved “antibody-drug conjugate” (ADC) from Roche, a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them without harming the body’s healthy cells. This also means that the number of adverse events can be reduced compared to the currently approved standard treatment.

“Kadcyla represents major progress for patients in the treatment of HER2-positive advanced breast cancer. Studies showed that patients lived considerably longer after treatment with Kadcyla than after standard treatment. The drug ticks the key boxes: efficacy, safety profile and enhanced quality of life,” says Titus Gylvin, Medical Director, Roche Pharma (Switzerland) Ltd.

The approval applies to the treatment of patients with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy and whose tumour continues to worsen despite multiple therapies in some cases. Patients in a Phase III study lived on average almost half a year longer (5.8 months) on the drug than on standard care. Kadcyla is not given unless a pre-treatment diagnostic test shows a potential for successful treatment. This enables it to be used efficiently in the health care system.

In February 2013 the drug was approved by the US Food and Drug Administration (FDA). Switzerland is the first European country to approve Kadcyla.

Kadcyla is made up of the antibody, trastuzumab, and chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1 and it is the first Roche ADC approved by the FDA and Swissmedic. Roche has been researching the principle of antibody-drug conjugation for over a decade and has eight ADCs in Phase I or Phase II studies for various types of cancer.

Efficacy of Kadcyla

The approval of Kadcyla is based on results from EMILIA, an international, Phase III, randomised, open-label study comparing Kadcyla alone to lapatinib in combination with Xeloda (capecitabine) in 991 patients with HER2-positive locally advanced or metastatic breast cancer who had previously been treated with Herceptin and a taxane chemotherapy. The study yielded the following results:1

  • The study met both co-primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS; as assessed by an independent review committee).
  • People who received Kadcyla had a significant survival benefit, living a median of 5.8 months longer (OS) than those who received the combination of lapatinib and Xeloda, the standard of care in this setting (hazard ratio [HR] = 0.68; 32 percent reduction in the risk of death, p < 0.001; median OS: 30.9 months vs. 25.1 months).
  • People who received Kadcyla lived significantly longer without their disease getting worse (PFS) compared to those who received lapatinib plus Xeloda (HR = 0.65; 35 percent reduction in the risk of disease worsening or death, p < 0.0001; median PFS: 9.6 months vs. 6.4 months).
  • No new safety signals were observed and adverse events (AEs) were consistent with those seen in previous studies, with fewer people who received Kadcyla experiencing Grade 3 or higher (severe) AEs than those who received lapatinib plus Xeloda (43.1 percent vs. 59.2 percent).

About Kadcyla

Kadcyla is an ADC being studied in HER2-positive cancers. It is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer. Like Herceptin, Kadcyla is thought to bind to HER2-positive cells and block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cancer cells. Kadcyla is taken up by those cells and destroys them by releasing the DM1 inside the cells.

About breast cancer

Breast cancer is the most common cancer among women worldwide.2 Each year over 5,000 Swiss women3 develop breast cancer. 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.4

HER2-positive cancer is a particularly aggressive form of breast cancer.5

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.

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References
1 Verma S, et al. Trastuzumab Emtansine for HER2-positive Advanced Breast Cancer. N Engl J Med 2012; 367:1783-1791.
2 Ferlay J, et al. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available at: http://globocan.iarc.fr.
3 Swiss National Institute for Cancer Epidemiology and Registration (NICER). May 2012, http://www.nicer.org/default.aspx?NavigationID=42.
4 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; 131:18-43.
5 Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl J Med 2011; 365:1273-83.