Trastuzumab-DM1: Phase II data

The open-label, international Phase II TDM4450g trial in 137 treatment-naïve patients showed that 3.6 mg/kg IV T-DM1 every 3 weeks produced an ORR of 48%, including 3 complete responses (CR) and 29 partial responses (PR), plus 22 cases of stable disease (SD). The active-control arm consisting of Herceptin trastuzumab plus Taxotere docetaxel produced an ORR of 41%, including 1 CR and 28 PRs, plus 29 cases of SD. CBR, defined as CR, PR and SD >6 months, was 55.2% for T-DM1 vs. 57.1% for Herceptin plus Taxotere. Rates of >=grade 3 adverse events were 37.3% for T-DM1 vs. 75% for Herceptin plus Taxotere. The most common T-DM1-related adverse events were nausea, fatigue and pyrexia. Data were presented at the European Society for Medical Oncology meeting in Milan. ...