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Roche’s T-DM1 over next hurdle
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Clinical TrialsEUSwitzerland

Roche’s T-DM1 over next hurdle

28.08.2012 - Swiss Roche AG reports its antibody-drug conjugate trastuzumab emtansine (T-DM1) improves overall breast cancer survival – and files MAAs.

After first promising news in spring Basel-headquartered F. Hoffmann-La Roche AG adds more substantiating Phase III data concerning the benefit of its antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1). On 27 August, the company and its licence partner ImmunoGen announced that the conjugate not only significantly improved progression-free survival (PFS) but also overall survival (OS) in patients with metastatic breast cancer. Patient data – which will be presented at an upcoming medical meeting – stems from the EMILIA Phase III trial. In EMILIA, the new drug was tested on 991 patients with HER2-positive non-resectable locally advanced or metastatic breast cancer who had previously unsuccessfully received trastuzumab (Herceptin) plus chemotherapy. Enrolled patients either fell into the T-DM1-only group or into the control, standard-of-care group receiving lapatinib (Tykerb) plus capecitabine (Xeloda). Roche also announced that it is about to submit the marketing application for T-DM1 to the European Medicines Agency (EMA).

 Genentech Inc., a Roche subsidiary situated in San Francisco (USA), is the developer of T-DM1. The company has already filed a marketing application for the drug to the Food and Drug Administration (FDA) in the US. The development was accomplished under an agreement with ImmunoGen, Inc. from Waltham (USA). The company from Massachusetts provides the linker chemistry and the compound drug’s cancer killing agent, which is targeted by the antibody (trastuzumab) to Her2neu tumour cell receptors. ImmunoGen calls its technology TAP, Targeted Antibody Payload. The cytotoxic agent is a derivative of maytansine that inhibits the assembly of microtubules. Maytansines are potent toxins that naturally occur in the shrubs and trees of the Genus Maytenus spp.

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