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GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)
Date:5/16/2008

ading dose) or TYKERB alone (1500 mg QD). Patients were heavily pre-treated and had received a median of six prior anti-cancer regimens. Patients had received a median of three prior lines of trastuzumab (1).

The primary endpoint of the study was progression-free survival, and secondary endpoints included clinical benefit rate (CR+PR+SD greater than or equal to 24 weeks), response rate, and overall survival. If patients progressed on the TYKERB monotherapy arm after four weeks of therapy, they could cross over to receive the combination of TYKERB + trastuzumab. Adverse events were similar in both arms, with Grade 1/2 diarrhea higher in the TYKERB + trastuzumab arm (53 percent vs. 41 percent; p=0.03). Two patients in the combination arm and one patient in the TYKERB monotherapy arm experienced symptomatic decreases in left ventricle ejection fracture (LVEF); one patient in the TYKERB + trastuzumab arm died due to a pulmonary thromboembolism with progressive malignant pleural effusions; two patients with LVEF decrease later recovered. Isolated cases of asymptomatic transient decreases in LVEF were noted in both treatment arms (1).

Additional Breast Cancer Data for Investigational Uses of TYKERB to be Presented at ASCO

GSK Oncology will also be presenting for the first time results of two studies evaluating TYKERB in combination with other targeted therapies, including TYKERB + pazopanib, GSK's investigational, oral, multikinase angiogenesis inhibitor, and TYKERB + bevacizumab. Final results from a trial evaluating TYKERB monotherapy in inflammatory breast cancer (IBC) will also be presented on-site. For more information on date and time of presentation, visit http://www.asco.org.

"The breadth of data to be presented at ASCO this year is truly remarkable and signifies the commitment of GSK Oncology to being at the forefront of cancer research," said Paolo Paoletti, M.D., Senior Vice President o
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SOURCE GlaxoSmithKline
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