ImmunoGen,
Inc. (Nasdaq: IMGN), a biotechnology
company that develops anticancer products using its Targeted Antibody
Payload (TAP) technology, today announced that Roche 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.
"The topline results reported today underscore the significance of
trastuzumab emtansine and its potential to help patients," commented
Daniel Junius, President and CEO. "We're delighted with these results
and with Roche's plans to submit trastuzumab emtansine for marketing
approval. We look forward to seeing the detailed study data at an
upcoming medical meeting."
Trastuzumab emtansine is in Phase III testing for treatment of
HER2-positive mBC in multiple clinical settings in the EMILIA, MARIANNE,
and TH3RESA trials, and in Phase II testing for adjuvant/neoadjuvant use
for earlier-stage disease.
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