Bayer recently announced the results of its Phase III trial for regorafenib (BAY 73-4506), which is designed for patients with metastatic and/or unresectable GIST that have failed both imatinib and sunitinib.
Results from the trial showed a statistically significant improvement in progression-free survival, and the safety and tolerability of regorafenib were consistent with what had been seen in earlier studies.
Data from this study will be presented at an upcoming scientific meeting, and Bayer has plans to file for U.S. approval of regorafenib for the treatment of metastatic GIST.
This is of course a potentially exciting development as effective third-line drugs are sorely needed, and we will be sure to report any further information as soon as it becomes available.
