DM1 Moves Ahead

[Joe]

ImmunoGen, Inc. Earns Milestone Payment with Genentech's Start of Trastuzumab-DM1 (T-DM1) Phase III Clinical Testing; Other T-DM1 Progress Reported

Last update: 11:00 a.m. EST March 2, 2009
WALTHAM, Mass., Mar 02, 2009 (BUSINESS WIRE) ImmunoGen Inc a biopharmaceutical company that develops targeted anticancer therapeutics, today announced several favorable developments related to T-DM1. T-DM1 comprises ImmunoGen's DM1 cell-killing agent linked to Genentech's anti-HER2 antibody, trastuzumab, and is in development by Genentech (US) and Roche (ex-US).
Update on Phase III Evaluation of T-DM1 as a 2nd-Line Treatment for HER2+ MBC
Patient dosing has begun in a Genentech/Roche Phase III trial evaluating T-DM1 as a second-line treatment for HER2-positive metastatic breast cancer (MBC). This event triggers a $6.5 million milestone payment to ImmunoGen. The 580-patient randomized EMILIA trial compares T-DM1, used as a single agent, to capecitabine plus lapatinib, and is anticipated to include approximately 260 clinical centers on a global basis.
Update on Phase II Evaluation of T-DM1 as a 3rd-Line Treatment for HER2+ MBC
Genentech disclosed today that patient enrollment is progressing ahead of schedule in the Phase II trial assessing T-DM1 as a third-line treatment for HER2-positive MBC. Genentech expects patient enrollment to be completed during the first quarter of 2009, and final data from this study to be available in the first quarter of 2010. Genentech has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the US Food and Drug Administration (FDA).
T-DM1: Potential Evaluation for Adjuvant Use
Genentech disclosed today that it is now considering conducting trials to evaluate T-DM1 as an adjuvant treatment for HER2-positive breast cancer.
"T-DM1 is being developed with a rapid and broad strategy," commented Daniel Junius, President and Chief Executive Officer. "We believe the updates announced today are exciting news not only for ImmunoGen, but -- more importantly -- potentially also for patients with HER2-positive breast cancer."

Regards
Joe