FONT-SIZE Plus   Neg

Bayer: Late Stage Study Of Regorafenib Meets Primary Goal In Tumor Patients

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Large U.S. companies are holding trillions of dollars overseas in an effort to avoid U.S. taxes, with big-name firms like Apple (AAPL), Pfizer (PFE) and PepsiCo (PEP) named as notable examples. This is the claim made by a pair of non-profit groups, who released a study based on the firms' financial statements. Software maker Adobe Systems Inc. (ADBE) Tuesday detailed an outlook for the full year 2016 indicated to miss Wall Street estimates, sending its shares down 8 percent in after-hours trading. Adobe expects full-year 2016 revenues of about $5.7 billion and an adjusted earnings of $2.70 per share. Analysts... Enterprise software maker Adobe (ADBE) provided updated guidance on Tuesday, predicting strong growth over the next three years by giving 2016 projections that are below what market analysts are currently expecting.
comments powered by Disqus
Follow RTT