GlaxoSmithKline stops enrollment in phase 3 trial of Tykerb for breast cancer after meeting endpoint

By Lisa Kerner

Erie, Pa., April 3 - GlaxoSmithKline said it has halted enrollment in its phase 3 clinical trial evaluating the combination of Tykerb (lapatinib ditosylate) and capecitabine (Xeloda) versus capecitabine alone.

GlaxoSmithKline said a pre-planned interim analysis of 321 patients in the study showed statistically significant results which exceeded the primary endpoint of a 50% increase in time to disease progression in the combination arm compared with the capecitabine alone arm.

The company said it halted enrolment based on unanimous recommendation of an Independent Data Monitoring Committee, which reviewed the pre-planned interim analysis.

The multicenter, randomized, open-label trial studied women with refractory advanced or metastatic breast cancer with documented ErbB2 (HER2) overexpression and whose disease progressed following treatment with trastuzumab (Herceptin) and other cancer therapies.

All women currently enrolled in the trial will continue to be followed. Those receiving capecitabine alone will be offered the option of switching to the combination therapy of capecitabine and Tykerb, according to a company news release.

"We are extremely encouraged by these data which suggest that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic ErbB2 positive breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin," senior vice president of the Oncology Medicine Development Center Dr. Paolo Paoletti said in a company news release.

"On the basis of this and other data we now plan to file in the United States and Europe during the second half of 2006."

The World Health Organization reports that more than one million cases of breast cancer are diagnosed annually.

Tykerb is being developed by GlaxoSmithKline as an orally administered therapy for breast cancer and other solid tumors. It is a small molecule that inhibits the tyrosine kinase components of ErbB1 and ErbB2 receptors.

GlaxoSmithKline is a research-based pharmaceutical and healthcare company based in Research Triangle Park, N.C.

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