More highlights from ESMO Congress

In further news coming out at the European Society of Medical Oncology (ESMO) Congress taking place in Vienna, Austria (see also The Pharma Letter October 1), USA-based ImmunoGen (Nasdaq: IMGN) announced overall survival data for its trastuzumab emtansine (T-DM1) Phase III EMILIA trial, showing that the product reduced the risk of death by 32% compared to the standard-of-care treatment arm of the trial.

Trastuzumab emtansine is in global development by Swiss drug major Roche under an agreement between its subsidiary Genentech and ImmunoGen and utilizes ImmunoGen’s TAP technology with the trastuzumab antibody. Genentech and Roche have applied for marketing approval of trastuzumab emtansine in the USA and Europe, respectively.

The EMILIA trial was designed to evaluate trastuzumab emtansine for the treatment of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin) and a taxane. Patients enrolled were randomized to treatment either with trastuzumab emtansine - used alone - or with lapatinib (Tykerb) plus capecitabine (Xeloda), standard-of-care in this setting. EMILIA progression-free survival (PFS) and tolerability findings were previously reported at the American Society of Clinical Oncology (ASCO) annual meeting in June 2012: patients treated with trastuzumab emtansine had a significant improvement in PFS (hazard ratio=0.65, p<0.0001) and experienced fewer Grade 3 or greater (severe) adverse events (40.8% versus 57.0%) than those treated with standard-of-care. PFS and OS are co-primary endpoints of the EMILIA trial.