Subcutaneous Herceptin trastuzumab: Additional Phase III data

Additional data from the open-label, international Phase III HannaH trial in 596 patients with HER2-positive early breast cancer showed that subcutaneous Herceptin produced a complete pathologic response rate, a co-primary endpoint, of 45.4% vs. 40.7% for IV Herceptin. Additionally, serum trastuzumab concentration, also a co-primary endpoint, measured just prior to surgery was 69 µg/mL for subcutaneous Herceptin vs. 51.8 µg/mL for IV Herceptin. Data were presented at the European Breast Cancer meeting in Vienna. Roche previously reported that subcutaneous Herceptin given on day 1 of a 21-day cycle for 18 cycles met the co-primary endpoints of comparable serum trastuzumab concentrations during the first 8 cycles of treatment and comparable complete pathologic response rates between treatment cycles 8 and 9 vs. IV Herceptin (see BioCentury, Oct. 24, 2011). ...