Biotechnology company ImmunoGen, Inc. (IMGN), Sunday announced results from the trastuzumab emtansine Phase III EMILIA trial. The study is indicated in the treatment of metastatic breast cancer that has progressed after treatment with trastuzumab and a taxane in any setting - early or metastatic disease.
The trastuzumab emtansine EMILIA trial conducted by Roche comprises ImmunoGen's DM1 cancer cell-killing agent linked to the trastuzumab antibody developed by Genentech, a member of the Roche Group, using ImmunoGen's method of attachment.
The EMILIA 991-patient trial compares trastuzumab emtansine, used alone, to lapatinib (Tykerb) plus capecitabine (Xeloda) for the treatment of HER2-positive metastatic breast cancer that has progressed after treatment with trastuzumab (Herceptin) and a taxane in any setting.
The trial is being globally developed by Roche under an agreement between ImmunoGen and Genentech. Roche plans to apply this year for marketing approval of trastuzumab emtansine in the US and Europe using EMILIA data.
Treatment with trastuzumab emtansine significantly improved progression-free survival compared to treatment with lapatinib plus capecitabine, as assessed by an independent review committee. Median progression-free survival was 9.6 months compared to 6.4 months, respectively. Progression-free survival is a co-primary endpoint of the trial.
In the hazard ratio, trastuzumab emtansine was found to reduce the risk of cancer progression or death by 35 percent relative to treatment with lapatinib plus capecitabine.
Overall survival, also a co-primary endpoint, and its data "are not mature at this time," and longer follow up is required.
For trastuzumab emtansine-treated patients, estimated one-year survival was 84.7 percent and estimated two-year survival was 65.4 percent. For the patients receiving lapatinib plus capecitabine, estimated one-year and two-year survival rates were 77.0 percent and 47.5 percent, respectively.
Fewer trastuzumab emtansine-treated patients experienced adverse events than those treated with lapatinib plus capecitabine - 40.8 percent versus 57 percent, respectively.
The most common of the adverse events with trastuzumab emtansine were low platelet count, increased enzymes released by the liver/other organs, and anemia, consistent with previous studies. The most common adverse events with lapatinib plus capecitabine were diarrhea, hand-foot syndrome, vomiting, and neutropenia.
Trastuzumab emtansine is also in Phase III testing for treatment of HER2-positive metastatic breast cancer in the MARIANNE and TH3RESA trials.
IMGN last traded at $14.20, up $0.31 or 2.23%, on a volume of 0.59 million shares on the Nasdaq.
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