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GlaxoSmithKline (GSK) Stops Tykerb Arm of Breast-Cancer Trial



9/12/2011 7:45:27 AM

LONDON (MarketWatch) -- GlaxoSmithKline PLC /quotes/zigman/146635/quotes/nls/gsk GSK -1.83% Friday said it will stop administering breast cancer drug Tykerb alone to patients in a clinical trial, after an independent committee decided the medicine would probably produce worse results than Roche Holding AG's (ROG.VX) rival product Herceptin.

The three arms of the late-stage trial in which patients take Tykerb in combination with Herceptin, or trastuzamab, will continue as planned, GSK said in a statement.

"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."

The trial, known as ALTTO, is a randomized, multi-center, Phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2-positive primary breast cancer--an aggressive form of the disease--GSK said.


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