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GlaxoSmithKline receives positive data and halts enrolment in phase III trial of Tykerb (Lapatinib) in advanced breast cancer

07 Apr 2006 - Based on the unanimous recommendation of an Independent Data Monitoring Committee (IDMC), GlaxoSmithKline (GSK) announced that it has halted enrolment in its Phase III clinical trial evaluating the combination of Tykerb (lapatinib ditosylate) and capecitabine (Xeloda®) versus capecitabine alone. The trial evaluated women with refractory advanced or metastatic breast cancer who have documented ErbB2 (HER2) overexpression and whose disease progressed following treatment with trastuzumab (Herceptin) as well as other cancer therapies. A pre-planned interim analysis of 321 patients in the study yielded statistically significant results, exceeding the primary endpoint.
 
According to the study protocol, the pre-planned interim analysis was reviewed by the IDMC, which is comprised of medical oncology experts and a statistician. The IDMC unanimously recommended halting enrolment in the study because it exceeded its primary endpoint of time to disease progression, or TTP, for women receiving the combination of Tykerb and capecitabine. The IDMC made their recommendation based on pre-specified stopping rules outlined in their charter. All women currently enrolled in the trial will continue to be followed and those who are receiving capecitabine alone will be offered the option of switching to the combination therapy of capecitabine and Tykerb in consultation with their physician.
 
Tykerb, a small molecule that is administered orally, inhibits the tyrosine kinase components of ErbB1 and ErbB2 receptors. Stimulation of ErbB1 and ErbB2 is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastasis. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival. Tykerb is an experimental drug that does not have regulatory approval in any country for any use outside of clinical trials.