Anti-cancer drug T-DM1 benefits women with advanced breast cancer who have failed se...
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`The European Cancer Congress 2013
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`Anti-cancer drug T-DM1 benefits women with advanced
`breast cancer who have failed several previous treatments:
`results from TH3RESA trial
`
`Amsterdam, The Netherlands: First results from a phase III clinical trial of the combination drug,
`T-DM1, show that it significantly improves the length of time before the disease worsens in women
`with advanced HER2 positive breast cancer whose cancer has recurred or progressed despite
`previous treatments, including trastuzumab and lapatinib.
`
`In a late-breaking presentation to the 2013 European Cancer Congress (ECC2013)[1] today
`(Saturday), Professor Hans Wildiers will say: “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 – the length of time before disease progression or death, whichever occurs
`first – compared to standard therapy, and with a more favourable safety profile. Few drugs have
`been able to achieve both improved progression-free survival and a better toxicity profile. These
`results indicate this drug has important clinical benefit for patients.”
`
`T-DM1 is a conjugated monoclonal antibody in which trastuzumab[2] is combined with a cell-killing
`drug emtansine (DM1) to target and kill breast cancer cells that have large amounts of the protein
`HER2 on their cell surfaces – known as HER2 positive breast cancer. T-DM1 has already been
`shown to benefit patients with HER2 positive breast cancer that has spread to other parts of the body
`(metastasised), and who have already been treated with trastuzumab and a taxane-based
`chemotherapy.
`
`“Despite the availability of improved treatments, virtually all patients with HER2 positive
`metastatic breast cancer develop progressive disease and require additional therapies for palliation.
`Currently there is no clear standard of care for patients who progressed after two or more treatments
`for their disease, including the use of the anti-HER2 drugs trastuzumab and lapatinib, and new
`treatment options are needed for these patients,” says Prof Wildiers, who is adjunct head of clinic at
`the department of medical oncology, and coordinator of the chemotherapy and related clinical trial
`programme in the multidisciplinary breast centre at the University Hospitals Leuven, Belgium.
`
`The international phase III clinical trial, called TH3RESA, enrolled patients whose cancer was
`inoperable, or had recurred or metastasised after several treatments including trastuzumab and
`lapatinib. By February 2013, 602 patients had been randomised to receive 3.6 mg/kg intravenous
`infusion of T-DM1 every three weeks or a treatment of their physician’s choice (TPC). The majority
`(75%) had visceral disease (cancer that had spread to internal organs) and they had received a
`median[3] of four previous treatment regimens (excluding single agent hormonal therapy).
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`Results showed that median progression-free survival increased by nearly three months from 3.3
`months for the TPC patients to 6.2 months for patients receiving T-DM1. Among the T-DM1
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`http://www.ecco-org.eu/Amsterdam2013/Global/News/ECC-2013-Press-Releases-EN/201...
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`1/21/2015
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`IMMUNOGEN 2073, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`Anti-cancer drug T-DM1 benefits women with advanced breast cancer who have failed se...
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`patients, 31.3% showed a response to the drug, compared with 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. Patients in the TPC group,
`whose disease progressed, were given the option of crossing over into the T-DM1 arm and 44
`patients have done this so far. Generally, there were fewer serious adverse side-effects in the
`T-DM1 patients than in the TPC group.
`
`“These data reaffirm the potential of T-DM1 as a treatment for HER2-positive metastatic breast
`cancer. They demonstrate that T-DM1 has the potential to be a new treatment paradigm for this
`group of patients who currently have few options,” Prof Wildiers will say.
`
`“In the earlier, EMILIA trial, T-DM1 was shown to be superior to capecitabine and lapatinib in
`patients who had previously received trastuzumab and a taxane. TH3RESA demonstrates that
`T-DM1 offers statistically significant and clinically meaningful improvement in delaying disease
`progression compared to a treatment of physician's choice, which was predominantly trastuzumab
`and chemotherapy combinations, in patients who have previously received trastuzumab and
`lapatinib.
`
`“This trial will continue until the final overall survival analysis takes place or until the survival
`benefit for treatment with T-DM1 reaches statistical significance at an interim analysis. T-DM1 is
`also being tested both alone and in combination with pertuzumab in patients with previously
`untreated HER2 positive metastatic breast cancer in the MARIANNE trial,” he will conclude.
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`ECCO President, Professor Cornelis van de Velde, commented: “These results from the TH3RESA
`trial are important because they confirm and extend the usefulness of T-DM1 for the treatment of
`women with advanced HER2 positive breast cancer. Once HER2 positive breast cancer has recurred
`and metastasised, there are few treatment options available that show any clear benefit for women
`who have probably undergone several previous treatments for the disease. The fact that T-DM1
`extends progression-free survival is good news for these women.”
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`Abstract no: LBA15, “T-DM1 for HER2-positive metastatic breast cancer (MBC): Primary results
`from TH3RESA, a phase 3 study of T-DM1 vs treatment of physician's choice”. Breast cancer
`–advanced disease proffered papers session, 11.15 hrs CEST, Saturday 28 September, Hall 7.1.
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`[1] The 2013 European Cancer Congress is the 17th congress of the European CanCer Organisation
`(ECCO), the 38th congress of the European Society for Medical Oncology (ESMO) and the 32nd congress
`of European Society for Therapeutic Radiology and Oncology (ESTRO).
`[2] Trastuzumab, also known by its brand name Herceptin, is a drug that targets cancer cells that produce
`too much of a protein called HER2 (human epidermal growth factor receptor 2). Trastuzumab attaches to
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`ECC 2015
`ECCO
`website
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`http://www.ecco-org.eu/Amsterdam2013/Global/News/ECC-2013-Press-Releases-EN/201...
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`1/21/2015
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`IMMUNOGEN 2073, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`Anti-cancer drug T-DM1 benefits women with advanced breast cancer who have failed se...
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`www
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`http://www.ecco-org.eu/Amsterdam2013/Global/News/ECC-2013-Press-Releases-EN/201...
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`1/21/2015
`
`IMMUNOGEN 2073, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676