Adjuvant Tykerb, Herceptin miss in Phase III ALTTO trial

Adjuvant treatment of HER2-positive early breast cancer with oral Tykerb lapatinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) plus IV Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit missed the primary endpoint of improving disease-free survival (DFS) vs. Herceptin alone in the Phase III ALTTO trial. Adjuvant treatment with Tykerb plus Herceptin led to a four-year DFS rate of 88% vs. 86% for Herceptin alone (p=0.048). The primary endpoint was designed to test for superiority of Tykerb plus Herceptin vs. Herceptin alone with a p-value of 0.025 or less.

ALTTO was sponsored by GSK and conducted in collaboration with NIH's National Cancer Institute, the North Central Cancer Treatment Group and the Breast International Group. The open-label, international trial enrolled 8,381 patients with HER2-positive early breast cancer. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...