GSK study: Targeted therapy combination showed 14-month survival in advanced breast cancer patients
A GSK study revealed that patients with advanced breast cancer achieved a median overall survival of 14 months when treated with an investigational combination therapy.
GlaxoSmithKline plc (GSK) announced results from a Phase III clinical study where a combination of investigational TYKERB® (lapatinib) and HERCEPTIN® (trastuzumab) demonstrated a median overall survival of 14 months in women with advanced ErbB2-positive metastatic breast cancer. The findings were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium.
The study enrolled 296 women with ErbB2-positive breast cancer who had experienced recurrence despite prior therapies including trastuzumab. The results suggest that the lapatinib-trastuzumab combination may help overcome resistance to trastuzumab-based treatments.
"The clinical benefits brought forth by the lapatinib and trastuzumab combination are quite compelling," stated lead investigator Kimberly Blackwell, M.D., Duke University Medical Center. "It’s possible that, by lapatinib working inside the cell and trastuzumab working outside the cell, the combination of agents is able to provide a more complete anti-tumour attack."
Patients in the study were randomized to receive either lapatinib monotherapy or the combination of lapatinib and trastuzumab. The median overall survival was 14 months for the combination group, compared to 9.5 months for the lapatinib monotherapy group. Safety analysis indicated similar rates of adverse events between the groups, with a notable increase in diarrhea for the combination arm.
GSK notes that TYKERB® is currently indicated in combination with Xeloda® (capecitabine) for patients with advanced or metastatic breast cancer whose tumors overexpress ErbB2 and have received prior therapy including an anthracycline, a taxane, and Herceptin. TYKERB alone or in combination with HERCEPTIN is not approved in this setting.