Description Trastuzumab-DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech's trastuzumab antibody linked to ImmunoGen's cell-killing agent, DM1. T-DM1 combines two strategies: anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative).

Development Status A Phase III clinical trial evaluating T-DM1 for second-line HER2-positive metastatic breast cancer is planned. Phase II clinical trials evaluating T-DM1 for first-, second- and third-line HER2-positive metastatic breast cancer are ongoing, and a Phase Ib clinical trial in combination with pertuzumab for HER2-positive metastatic breast cancer patients who have progressed on Herceptin-based treatment is planned.

This molecule is being developed in collaboration with F. Hoffmann-La Roche and ImmunoGen, Inc.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

October 2008