GSK scales back breast cancer trial
pharmafile | September 12, 2011 | News story | Research and Development, Sales and Marketing | GSK, Tyverb
GSK has halted one of the four phase III studies that make up the ALTTO programme for its cancer drug Tyverb.
ALTTO has been running since 2007 and is designed to evaluate the use of Tyverb (lapatinib) in early breast cancer following surgery and compare it to Roche’s more established brand Herceptin (trastuzumab).
The programme’s four studies saw patients receive either Tyverb, Herceptin, Herceptin followed by Tyverb or a combination of Tyverb and Herceptin.
But GSK said its planned interim review of the trials found the Tyverb alone arm was unlikely to demonstrate non-inferiority to Herceptin alone with respect to disease-free survival.
Consequently patients assigned to the Tyverb alone arm of the trial will stopping taking that drug and discuss treatment options with their study physician.
The trial involves around 8,400 patients and GSK said the remaining three arms of the study programme would continue as planned.
Dominic Tyer
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