Updated on 5 June 2014
GSK's combination cancer drug fails in phase III trials
Singapore: Glaxosmithkline declared that the phase III study of two anti-HER2 agents lapatinib and trastuzumab did not meet the primary endpoint, as compared to the single therapy with trastuzumab treatment for early breast cancer. The results were presented at the 50th Annual Meeting of the American Society of Clinical Oncology, in Chicago.
Dr Rafael Amado, senior vice president, Oncology R&D at GSK, said that it was disappointing that the drug did not meet the end point, however the studies provided lots of information and knowledge on the biology of the disease, and this would help in focusing further research into the disease.
The combination drug, generated side effects like diarrhea, rash, hepatobiliary disorders as compared to trastuzumab alone. The process randomised 8,381 patients at nearly 1,000 research sites in 44 countries. Patient enrolment began in June 2007 and was completed in July 2011.
Dr Rafel said that GSK was most grateful to all the 8,381 patients across the world who participated in the research mission, and that this could be marked as their generous contribution to the scientific community.