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news.GlaxoSmithKline has reported positive results from the extension arm of a Phase II study on its first-in-class, oral small molecule HER2 kinase inhibitor, Tykerb.
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In this study of 49 patients, the combination of Tykerb plus capecitabine (Xeloda) showed a reduction in HER2-positive breast cancer that had spread to the brain and had progressed on Tykerbalone. Specifically, 20% of patients who received Tykerb plus capecitabine experienced at least a 50% volumetric reduction in measurable brain metastases; 37% of patients experienced a volumetric decrease that was greater than or equal to 20%. This is important because up to one-third of women with HER2-positive metastatic breast cancer may develop brain metastases during the course of their disease.
Tykerb, in combination with capecitabine, is approved in the US for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane and trastuzumab (Herceptin).
Paolo Paoletti, senior vice president of the oncology medicine development center at GlaxoSmithKline, said: “We plan to further study the effects of Tykerbin HER2-positive patients with brain metastases.”