A 'gutsy' phase 3 clinical trial in colorectal cancer


I'm finalizing one of our stories from the ASCO Gastrointestinal Cancers Symposium this week - that of regorafenib, a multi-targeted drug that showed a slight median survival advantage in metastatic colorectal cancer patients who had progressed on three or more lines of therapy. Regorafenib targets several different cancer growth pathways, which makes it unique and could explain why it works against tumors that have progressed on so many other therapies. And while the phase 1 data wasn't a slam dunk, it was decided that it would skip phase 2 and move directly to phase 3 -- a move one physician called "gutsy." But it worked and will most likely be approved -- much sooner than if the drug had traveled the traditional route. Another study, which followed the regorafenib presentation, was that of brivanib, another experimental targeted agent for metastatic colorectal cancer. This drug also showed positive results in phase 1 and was moved directly to phase 3. However, unlike regorafenib, the study turned out to be negative. It delayed cancer growth, but survival did not significantly improve.Both were considered promising drugs and had solid study designs, but one worked and one didn't.

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