GSK's combo breast cancer treatent fails in phase III
- GSK's phase III trial in women with HER2-positive breast cancer failed to meet the primary endpoint--improved DFS versus standard therapy.
- The trial compared combined lapatinib and trastuzumab with trastuzumab alone.
- Difference in the results between standard therapy versus the experimental combination regimen was only 2%.
This phase III, randomized, multicenter trial in scope, enrolling 8,000 women worldwide. The results: At four years, 88% of women treated with trastuzumab combined with lapatanib had four-year DFS, compared with 86% of women treated with trastuzumab alone.
GSK's response: Though they were disappointed with the results, they are pleased with the amount of clinical information they collected and documented about the biology of HER2-positive breast cancer in the adjuvant setting.
- http://www.pharmaceutical-business-review.com GSK's Phase III trial of breast cancer combination treatment fails to meet primary endpoint