Phase 3 Trial of Trastuzumab Emtansine for HER2-positive Metastatic Breast Cancer
Immunogen, Inc. announced that additional results from the Phase 3 EMILIA trial of trastuzumab emtansine for treatment of HER-2 positive metastatic breast cancer met one of the study's primary endpoint of progression-free survival.
The EMILIA trial enrolled 991 patients comparing trastuzumab emtansine alone to Tykerb (lapatinib; GlaxoSmithKline) plus Xeloda (capecitabine; Roche) for the treatment of HER2-positive metastatic breast cancer that has progressed after treatment with Herceptin (trastuzumab; Genentech) and a taxane in any setting (early or metastatic disease). Study findings showed treatment with trastuzumab emtansine significantly improved PFS compared to treatment with lapatinib plus capecitabine, as assessed by an independent review committee (median PFS 9.6 months vs. 6.4 months, respectively; hazard ratio=0.65; P<0.0001). Trastuzumab emtansine reduced the risk of cancer progression or death by 35% relative to treatment with lapatinib plus capecitabine.
In addition, for trastuzumab emtansine-treated patients, estimated one-year survival was 84.7% and estimated two-year survival was 65.4%. For the patients receiving lapatinib plus capecitabine, estimated one-year and two-year survival rates were 77.0 % and 47.5%, respectively.
Trastuzumab emtansine is an antibody-drug conjugate (ADC) comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells.
For more information call (781) 895-0600 or visit www.immunogen.com.