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GSK Study Showed Targeted Therapy Combination Achieved 14 Month Overall Survival in Patients with Advanced Breast Cancer
Date:12/11/2009

LONDON and PHILADELPHIA, Dec. 11 /PRNewswire/ -- In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). The results of the Phase III study in HER2-positive metastatic breast cancer were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (Dec. 9 - 13).

The study included 296 women with a type of breast cancer known as HER2-positive disease, characterized by an overexpression of the HER2 protein in the cancer cells. Patients enrolled in the study experienced recurrence of breast cancer despite a median of three prior trastuzumab-based therapies. The data presented at the San Antonio congress showed that patients overcame resistance to trastuzumab with the introduction of the lapatinib-trastuzumab combination.

"The clinical benefits brought forth by the lapatinib and trastuzumab combination are quite compelling and lead me to believe the agents may be acting together to form a sort of 'dual blockade' to obstruct the HER2 pathway necessary for the tumor to thrive," said primary investigator, Kimberly Blackwell, M.D., Duke University Medical Center.

Patients in the study were randomized to receive single agent lapatinib (1500 mg/daily) or a combination of lapatinib (1000 mg p.o. daily) plus trastuzumab (2 mg/kg). For those patients treated with monotherapy lapatinib, cross-over to the combination was allowed if the disease progressed after at least four weeks of therapy. Final analysis showed clinical activity for lapatinib in the control arm. Women treated with monotherapy lapatinib experienced a median overall survival of 9.5 months compared with 14 months when treated with the combination (median HR: 0.74, p=0.026).

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SOURCE GlaxoSmithKline
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