ImmunoGen Breast Cancer Drug Shows Positive Results; Shares Up

   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 [e-mail]

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