Shares of Immunogen Inc. (NASDAQ: IMGN) touched a new 52-week high and a 9-year high of $12.03 on Thursday. Roche Holding AG said an experimental drug T-DM1 was effective in a mid-stage study of breast cancer patients whose disease has spread.

The Waltham, Massachusetts-headquartered Immunogen said that Roche has disclosed positive top-line results from the first randomized trial assessing trastuzumab emtansine (T-DM1, previously known as trastuzumab-DM1) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

T-DM1 consists of ImmunoGen’s DM1 cancer cell-killing agent attached using the company’s linker to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group.

The top-line results disclosed by Roche were that patients treated with T-DM1 had a significant improvement in progression-free survival compared with patients treated with Herceptin (trastuzumab) plus chemotherapy (docetaxel) in the Phase II trial comparing these agents for first-line treatment for HER2-positive MBC.

The detailed findings from this randomized, 137-patient trial are being submitted for presentation at a future medical conference. Favorable preliminary data were reported previously from this trial at the 35th Congress of the European Society of Medical Oncology (ESMO), but progression-free survival data were not available at that time.

This top-line information about T-DM1’s performance in the first-line setting is very encouraging and adds to the favorable efficacy and safety data reported across a number of T-DM1 studies. We look forward to learning the detailed data when they are reported at a medical conference, said Daniel Junius, Chief Executive Officer of Immunogen.

Breast cancer is the most common malignancy in females and strikes about 1 million women a year globally, according to the World Health Organization (WHO).

Trastuzumab emtansine (the generic or International Non-proprietary Name for T-DM1) utilizes ImmunoGen’s Targeted Antibody Payload (TAP) technology with the trastuzumab antibody developed by Genentech. The compound is in global development by Roche under a collaboration agreement between ImmunoGen and Genentech.

T-DM1 is in Phase III testing for second-line and first-line treatment of HER2-positive MBC. A Phase II trial evaluating the safety of T-DM1 in the neoadjuvant/adjuvant setting began in late 2010.

Immunogen stock gapped open sharply higher April 7 at $9.61 compared to previous day's close of $9.30. The stock touched a new high of $12.03 on Thursday. The stock traded between $4.96 and $12.03 during the past 52 weeks.

The stock is currently trading up 23.16 percent at $11.45 on the NASDAQ Stock Market with a volume of 2.54 million shares at 11:29 am EDT.

NASDAQ Stock Market Breast cancer Medicine Breast cancer