Roche says that it has landed a promising set of survival and safety data from a mid-stage study of its closely-watched breast cancer treatment T-DM1. While keeping the actual data under wraps, investigators say that HER2-positive patients in the study "lived significantly longer with their disease under control--progression-free survival--and experienced fewer side effects typical of chemotherapy." The news is also a plus for ImmunoGen, which is partnered with Roche.
Roche had attempted to gain an early approval on T-DM1, an important follow-up therapy to the blockbuster Herceptin, only to be turned away by the FDA, which refused to accept the NDA. Investigators have been continuing a full set of studies, including Phase III trials, in anticipation of delivering a full set of data to back the therapy. T-DM1 has been designated one of Roche's most important development programs with the potential to go on and earn billions of dollars a year.
"These encouraging data support our ongoing development program for trastuzumab emtansine (T-DM1) in first-line HER2-positive metastatic breast cancer,'' said Hal Barron, M.D., Roche's head of global development. "Trastuzumab emtansine (T-DM1) is a novel treatment with the potential to improve outcomes for patients with HER2-positive breast cancer due to its efficacy and favourable safety profile."
"Although results will need to be replicated in ongoing larger trials, the news is clearly an incremental positive in Roche's efforts to protect its Herceptin franchise from biosimilar competition, which could materialise from 2014/2015 in Europe and 2019 in the United States," noted Deutsche Bank analyst Tim Race, according to a report in Reuters.
- check out the Roche release
- here's the story from Reuters
Special Report: T-DM1 - 10 promising late-stage cancer drugs