Media Release
`
`
`
`
`Basel, 20 November 2013
`
`Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer
` More than 70,000 people in Europe each year are diagnosed with advanced breast cancer, of whom
`approximately one in five will have HER2-positive disease
` There is currently no cure for advanced breast cancer, and whilst in recent years the outlook has
`improved, further treatments are needed to help ensure people continue to have options when their
`disease gets worse
`In a clinical study people with HER2-positive advanced breast cancer who were treated with Kadcyla
`survived almost six months longer than those receiving the standard treatment of lapatinib and
`Xeloda
` Patients also experienced fewer of the severe side effects commonly associated with chemotherapy, as
`Kadcyla’s targeted mode of action works to deliver the treatment directly to cancer cells, limiting
`damage to healthy tissues
`
`
`
`
`Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Kadcyla (trastuzumab emtansine or
`T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been
`approved by the European Commission for people with previously treated HER2-positive advanced breast
`cancer.
`
`Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive,
`unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab)
`and a taxane, separately or in combination. The indication also stipulates that those treated should either
`have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during
`or within six months of completing adjuvant therapy.
`
`“Kadcyla's approval in the EU is important because this type of targeted medicine has been shown in clinical
`studies to offer clear benefits for people with advanced HER2-positive breast cancer,” said Hal Barron, M.D.,
`Roche’s Chief Medical Officer and Head of Global Product Development. “Now that Kadcyla has been
`approved, we can begin discussions with the relevant EU reimbursement authorities to ensure that people
`who need this medicine can receive it as quickly as possible."
`
`
`
`
`
`
`
`F. Hoffmann-La Roche Ltd
`
`4070 Basel
`Switzerland
`
`Group Communications
`Roche Group Media Relations
`
`
`
`
`
`Tel. +41 61 688 88 88
`Fax +41 61 688 27 75
`www.roche.com
`
`1/4
`
`IMMUNOGEN 2267, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`The decision is based on results from the pivotal Phase III EMILIA study in which people previously treated
`with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomised to receive
`either Kadcyla or a standard treatment, lapatinib and Xeloda (capecitabine). People receiving Kadcyla
`survived significantly longer than those who received lapatanib and Xeloda (30.9 vs 25.1 months) and also
`lived for nearly 10 months (9.6 months) without their disease getting worse, a median of 3.2 months longer
`than those who received lapatinib and Xeloda. They also experienced fewer of the severe side effects
`commonly associated with chemotherapy, as Kadcyla’s targeted mode of action works to deliver the
`treatment directly to cancer cells, limiting damage to healthy tissues.
`
`About Kadcyla
`Kadcyla is the third targeted medicine Roche has developed for the treatment of HER2-positive breast cancer.
`It is a type of medicine called an antibody-drug conjugate and it connects two anti-cancer properties: the
`HER2 inhibition of trastuzumab (the active ingredient found in Herceptin) and the cytotoxic chemotherapy,
`DM1. The trastuzumab and the DM1 are joined together using a ‘stable’ linker to deliver DM1 directly to
`HER2-positive breast cancer cells.
`
`Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.
`
`About the EMILIA study
`The EU filing of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase
`III, randomised, open-label study comparing Kadcyla alone to the combination of lapatinib and Xeloda in
`991 patients with HER2-positive locally advanced breast cancer or metastatic breast cancer who had
`previously been treated with Herceptin and a taxane chemotherapy. Results include:
`
`
`Study arms
`Overall survival
`(OS, co-primary
`endpoint)
`
`
`
`Median OS
`
`Progression free
`survival
`(PFS, co-primary
`endpoint, independent
`review)
`
`
`Kadcyla
`
`lapatinib and Xeloda
`5.8 months difference
`HR=0.682 (95% CI: 0.548-0.849)
`32% reduction in the risk of dying
`Observed 23% improvement in median OS
`p=0.0006
`
`30.9 months
`
`25.1 months
`
`3.2 months difference
`HR=0.650 (95% CI: 0.549-0.771)
`35% reduction in the risk of disease worsening or death
`Observed 50% improvement in median PFS
`p<0.0001
`
`9.6 months
`
`6.4 months
`
`
`
`2/4
`
`IMMUNOGEN 2267, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Median PFS
`
`Response rate
`
`Median duration of
`response
`Safety profile
`
`Rate of Grade 3 or
`higher AEs
`
`Most common Grade 3
`or higher AEs
`
`
`
`
`
`43.6%
`
`12.6 months
`
`30.8%
`
`6.5 months
`
`Kadcyla was more tolerable than lapatinib and Xeloda
`
`43.1%
`
`59.2%
`
`For people receiving Kadcyla, the
`most common (occurring in more
`than 2% of patients) Grade 3 or
`higher AEs were:
` thrombocytopenia (12.9%),
`elevated AST (4.3%), elevated ALT
`(2.9%), anaemia (2.7%), fatigue
`(2.4%), hypokalemia (2.2%) and
`neutropenia (2%).
`
`For people receiving lapatinib and
`Xeloda, the most common
`(occurring in more than 2% of
`patients) Grade 3 or higher AEs
`were:
`diarrhoea (20.7%), hand and foot
`syndrome (16.4%), vomiting (4.5%),
`neutropenia (4.1%), fatigue (3.5%),
`nausea (2.5%) and mucosal
`inflammation (2.3%).
`
`
`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.
`
`
`
`
`
`
`3/4
`
`IMMUNOGEN 2267, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`Additional information
`Roche in Oncology: www.roche.com/de/media/media_backgrounder/media_oncology.htm
`
`
`Roche Group Media Relations
`Phone: +41 61 688 8888 / e-mail: basel.mediaoffice@roche.com
`
`- Alexander Klauser (Head)
`
`- Silvia Dobry
`
`- Daniel Grotzky
`
`- Štěpán Kráčala
`
`
`
`
`4/4
`
`IMMUNOGEN 2267, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
`
`