ImmunoGen celebrates T-DM1 Phase III success with market plans

ImmunoGen's ($IMGN) antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1) has significantly improved survival in a Phase III trial in women with advanced breast cancer, and the agent has been submitted for marketing approval.

T-DM1, pitched as a successor to Genentech's hugely successful anti-cancer monoclonal antibody Herceptin (trastuzumab), uses ImmunoGen's Targeted Antibody Payload (TAP) technology to link the antibody to the chemotherapeutic DM1 to deliver treatment directly to the tumor.

Genentech, which is a member of the Roche ($RHHBY) group, has submitted a Biologics License Application (BLA) to request approval to market the drug in the U.S., and Roche is planning a Marketing Authorization Application (MAA) to the European Medicines Agency for launch in Europe. T-DM1 is in global development with Roche under an agreement between ImmunoGen and Genentech.

In the study, known as the EMILIA Phase III trial, women with metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane were given T-DM1. The women receiving T-DM1 survived for significantly longer than those receiving just standard treatment, with fewer side effects. The treatment also improved progression-free survival. As a result of this, the women on the standard treatment arm had the option to switch to T-DM1.

"It's impressive that the overall survival endpoint has already been met--this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities," commented Daniel Junius, ImmunoGen's president and CEO. "We developed our TAP technology to achieve more effective, better tolerated anti-cancer therapies, and are delighted that people treated with trastuzumab emtansine survived significantly longer than those who received a standard therapy."

T-DM1 is also in Phase III trials in women with newly diagnosed and previously treated breast cancer. And trials in earlier-stage disease are also planned, which will expand the market for the drug. There are nearly 230,000 new cases of breast cancer every year, according to the American Cancer Society. Genentech is planning to open an Expanded Access Program (EAP) in the U.S. to grant certain women access to the drug while the company seeks regulatory approval.

ImmunoGen has 10 TAP compounds in clinical development, of which three are wholly owned by the company, and its shares have risen 32% in the previous 12 months, according to

- read the press release from ImmunoGen
- see the press release from Genentech
- check out the article on

Special Report: T-DM1 – Top 10 Late-Stage Cancer Drugs – 2012

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