Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). EMILIA is the most advanced trastuzumab emtansine Phase III study, and evaluates the compound for the treatment of HER2-positive metastatic breast cancer (mBC) in patients who have previously received treatment with trastuzumab (Herceptin®) and a taxane.
Roche said that, based on these findings, it plans to apply for
marketing approval of trastuzumab emtansine for HER2-positive mBC in the
"The topline results reported today underscore the significance of
trastuzumab emtansine and its potential to help patients," commented
Trastuzumab emtansine is in Phase III testing for treatment of HER2-positive mBC in multiple clinical settings in the EMILIA, MARIANNE, and TH3RESA trials, and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease.
Conference Call Information
ImmunoGen is holding a conference call today at
About ImmunoGen's TAP Technology
ImmunoGen developed its TAP technology to achieve more effective, better tolerated anticancer drugs. A TAP compound consists of a manufactured antibody that binds specifically to a target found on tumor cells with one of the Company's highly potent cancer-killing agents attached as a payload. The antibody serves to target the payload specifically to the cancer cells, and the payload serves to kill the cancer cells. In the case of some compounds that use ImmunoGen's TAP technology (trastuzumab emtansine and ImmunoGen's IMGN529 compound), the antibody component also has meaningful anticancer activity.
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including trastuzumab emtansine (T-DM1), including risks related to
clinical studies and regulatory submissions, their timings and results.
A review of these risks can be found in ImmunoGen's Annual Report on
Form 10-K for the fiscal year ended
Tykerb® is a registered trademark of GlaxoSmithKline plc.
Xeloda® is a registered trademark of Roche.
Herceptin® is a registered trademark of
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