Biotech Values

[NP1986]

Lapatinib monotherapy inferior to Herceptin as adjuvant therapy

A planned interim review of early data from ALTTO a Phase III, four arm study of adjuvant lapatinib (Tykerb/Tyverb®), trastuzumab, their sequence and their combination in patients with HER2 positive early stage breast cancer, has resulted in a change to the ongoing study. The independent data monitoring committee that carried out the review has recommended that three of the trial arms continue without modification. However, the committee has indicated that the lapatinib alone arm is unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival. Consequent to this finding, patients assigned to the lapatinib alone arm of the trial will discontinue lapatinib and discuss treatment options with their study physician. This study is fully recruited and the remaining three arms of the trial will continue as planned.

http://www.gsk.com/media/pressreleases/2011/2011-pressrelease-614837.htm