ImmunoGen Reports Roche Has Provided an Update on the MARIANNE Trial
The study evaluated three HER2-targeted regimens - Kadcyla® (ado-trastuzumab emtansine) plus Perjeta® (pertuzumab), Kadcyla alone, and Herceptin® (trastuzumab) plus taxane chemotherapy - in people with previously untreated HER2-positive metastatic breast cancer (mBC). Kadcyla utilizes ImmunoGen's ADC technology and is already approved to treat patients with HER2-positive mBC who previously received trastuzumab and a taxane.
Roche has reported the
"While we are disappointed by this unexpected outcome, we are pleased
that so many patients can benefit from Kadcyla with its already approved
use and also with the breadth of Roche's Kadcyla clinical development
program," commented
Roche expects data from the
This event has no impact on ImmunoGen's financial guidance for the Company's 2015 fiscal year, or on the approved use of Kadcyla.
About Roche's MARIANNE Study
This Phase III study (NCT01120184; BO22589) is an international, randomized, multicenter, three-arm study involving 1,095 people with HER2-positive mBC. People with mBC at diagnosis and those whose disease had worsened following either neoadjuvant or adjuvant treatment were eligible for enrollment in the study.
The primary endpoint of the
About
Herceptin®, Kadcyla®, and Perjeta® are
registered trademarks of
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 Kadcyla, including risks related to clinical studies and
regulatory interactions, 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
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