 |
|||
     |
|||
|
 Trastuzumab emtansine (also known as T-DM1) consists of our proprietary DM1 cancer cell-killing agent attached to the HER2-binding antibody, trastuzumab, developed by Genentech (a member of the Roche Group) using our linker and methods of attachment. Trastuzumab emtansine is in global development by Roche under a collaboration agreement between ImmunoGen and Genentech. Development for 2nd-line Treatment of Advanced HER2+ Breast Cancer Trastuzumab emtansine is being evaluated in a Phase III trial, EMILIA, for 2nd-line* use. Roche expects to report results in 2012 and to use them to support global regulatory submission for the compound. EMILIA compares trastuzumab emtansine – used as a single agent – versus lapatinib (Tykerbâ) plus capecitabine (Xelodaâ). Development for 1st-line Treatment of Advanced HER2+ Breast Cancer Trastuzumab emtansine is being evaluated in a Phase III trial, MARIANNE, for 1st-line use. Roche expects to use results from MARIANNE to support regulatory submission for first-line use in 2014. This randomized trial began in July 2010 and compares trastuzumab emtansine used as a single agent versus trastuzumab emtansine used in combination with pertuzumab versus trastuzumab (Herceptinâ) plus a taxane. Findings from a randomized, 137-patient Phase II trial were presented at a medical conference in September 2011. The results indicate that trastuzumab emtansine, as a single agent, offers efficacy and tolerability benefits compared with current first-line standard of care (Herceptinâ plus chemotherapy). On December 10, 2010, at the San Antonio Breast Cancer Symposium (SABCS), encouraging clinical data were announced from a Phase Ib/II trial conducted by Roche to assess trastuzumab emtansine used in combination with pertuzumab for the 1st-line treatment of metastatic breast cancer. Development for Early Stage HER2+ Breast Cancer A Phase II trial to evaluate trastuzumab emtansine for early stage HER2+ breast cancer (adjuvant and neoadjuvant use) began enrolling patients in October 2010.
Other Potential Uses In April 2011 at the annual meeting of the American Association for Cancer Research, Chugai (a member of the Roche Group) reported promising preclinical data with trastuzumab emtansine for HER2+ gastric cancer. *Patients must have received prior treatment that included both a taxane (alone or in combination with another agent) and trastuzumab in the adjuvant, locally advanced or metastatic setting. Tykerbâ is a registered trademark of GlaxoSmithKline plc. |
||
|
|||
