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`Page 1 of 2
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`© Roche/Genentech. T-DM1 structure
`
`CLINICAL TRIALS
`
`Roche reports new T-DM1 results
`
`30.09.2013 - New results with Roche’s antibody drug conjugate T-DM1 suggest the drug is a more
`effective breast cancer therapy than trastuzumab and lapatinib.
`Interim results from the TH3RESA Phase III study were presented at the European Cancer
`Congress in Amsterdam. In HER2-positive breast cancer patients whose cancer was
`inoperable,had recurred or metastasised after several treatments including trastuzumab and
`lapatinib, progression-free survival (PFS) increased by nearly three months.
`In 602 patients randomised to receive 3.6 mg/kg intravenous infusion of the antibody-drug
`conjugate (ADC) every three weeks compared to a treatment of their physician's choice, a PFS of
`3.3 months was observed for the TPC patients compared to 6.2 months for patients receiving
`T-DM1. Among the T-DM1 patients, 31.3% showed a response to the drug, compared to 8.6% of the
`TPC patients. An interim analysis of overall patient survival showed a similar trend, but it did not
`reach the level at which a statistically significant benefit for T-DM1 treatment could be
`confirmed. Generally, there were fewer serious adverse side-effects in the T-DM1 patients than in
`the TPC group.
`Lead investigator Hans Wildiers said: "This study shows that even in heavily pre-treated women,
`75% of whom had cancer that has spread to the internal organs, T-DM1 nearly doubles
`progression-free survival. Few drugs have been able to achieve both improved progression-free
`survival and a better toxicity profile."
`T-DM1 links Roche’s Her2-specific antibody trastuzumab with the tubulin blocker emtansine
`(DM1) to target and kill breast cancer cells that overexpress the HER2 protein on their cell
`surfaces. The ADC has
`already been approved as a treatment for metastatic and recurrent
`breast cancer–patient in which herceptin + taxane therapy failed under the brand name Kadcyla.
`© eurobiotechnews.eu/tg
`
`http://www.european-biotechnology-news.com/news/news/2013-04/roche-reports-new-t-d...
`
`1/21/2015
`
`IMMUNOGEN 2072, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Roche reports new T-DM1 results - European Biotechnology News
`
`Page 2 of 2
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`http://www.european-biotechnology-news.com/news/news/2013-04/roche-reports-new-t-dm1-
`results.html
`
`FIND MORE ARTICLES IN OUR ARCHIVE
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`http://www.european-biotechnology-news.com/news/news/2013-04/roche-reports-new-t-d...
`
`1/21/2015
`
`IMMUNOGEN 2072, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
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