Bayer AG's (BYR.L,BAYRY.PK,BAYZF.PK) Bayer HealthCare on Tuesday announced positive results from its Phase III trial GRID evaluating its investigational compound regorafenib for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors, or GIST, whose disease has progressed despite prior treatment with imatinib and sunitinib.
The trial met its primary endpoint of statistically significantly improving progression-free survival. The safety and tolerability of regorafenib were generally as expected in the study. Detailed data from the study are expected to be presented at an upcoming scientific meeting.
Kemal Malik, Head of Global Development and member of the Bayer HealthCare Executive Committee, said, "Additional treatment options are needed for GIST patients after failure of approved drugs. These findings may represent important progress in this difficult-to-treat disease with high unmet patient need."
Bayer plans to submit regorafenib for marketing authorization in the treatment of metastatic and/or unresectable GIST based on these data.
Regorafenib has also shown positive results in a Phase III trial for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies. Bayer plans to submit regorafenib for marketing authorization in this indication in the first half of 2012.
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by RTT Staff Writer
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