ImmunoGen (IMGN) Reports Positive Top-Line Results from T-DM1 EMILIA Phase III
Tweet
Share
E-mailGet Alerts IMGN Hot Sheet
Join SI Premium – FREE
ImmunoGen, Inc. (Nasdaq: IMGN), announced that Roche (OTC: RHHBY) has announced positive topline results from its trastuzumab emtansine (T-DM1) EMILIA Phase III trial. Trastuzumab emtansine consists of ImmunoGen's potent cancer-killing agent, DM1, attached to the HER2-targeting antibody, trastuzumab, and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
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 US (through Genentech) and in Europe. Roche also noted that the safety profile of trastuzumab emtansine in the EMILIA trial was consistent with previous studies and that final results for overall survival (OS) are not yet mature. PFS and overall survival are co-primary efficacy endpoints of EMILIA.
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 US (through Genentech) and in Europe. Roche also noted that the safety profile of trastuzumab emtansine in the EMILIA trial was consistent with previous studies and that final results for overall survival (OS) are not yet mature. PFS and overall survival are co-primary efficacy endpoints of EMILIA.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
- Kimbell Royalty closes $221.2M mineral rights acquisition
- Alzamend Neuro (ALZN) files for 98.4M share offering by selling stockholders
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
