By Saabira Chaudhuri
ImmunoGen Inc. (IMGN) said updated results from a study by Roche
Holding AG (ROG.VX, RHHBY, RO.EB) focused on a breast cancer drug
that uses ImmunoGen's technology were positive.
Shares jumped 23% to $17 in recent premarket trading. The stock
is up 33% in the past 12 months.
The biotechnology company said the Phase three study found that
patients with metastatic HER2-positive breast cancer who have
previously received trastuzumab and a taxane and were then treated
with trastuzumab emtansine had a significant improvement in overall
survival compared with those randomized to standard-of-care
therapy.
The breast cancer drug is in global development by Roche under
an agreement between ImmunoGen and Roche unit Genentech.
ImmunoGen's technology uses monoclonal antibodies to deliver one of
the company's proprietary cancer-killing agents specifically to
tumor cells.
Separately, ImmunoGen said Genentech has submitted a biologics
license application for trastuzumab emtansine to the U.S. Food and
Drug Administration, and Roche expects to soon submit a marketing
authorization application to the European Medicines Agency.
"It's impressive that the overall survival endpoint has already
been met--this had been expected to occur well after the submission
of the biologics license application and marketing authorization
application to the regulatory authorities," said Chief Executive
Daniel Junius.
Patients enrolled in the latest study were randomized to
treatment with trastuzumab emtansine used alone, or with lapatinib
plus capecitabine, which is the standard-of-care.
Roche has Phase three trials underway evaluating trastuzumab
emtansine both for newly diagnosed and for previously treated
metastatic HER2-positive breast cancer. Additionally, it plans to
initiate registration trials beginning in 2013 to evaluate the
compound for three settings in earlier-stage disease: adjuvant use;
neoadjuvant use; and treatment of patients with residual invasive
disease following standard neoadjuvant therapy.
The first results from the study, reported in June, showed that
the drug significantly improved progression-free survival compared
to standard-of-care therapy and that fewer of the trastuzumab
emtansine-treated patients experienced grade three or severe
adverse events.
Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires