Phase III Trial of Investigational Compound Regorafenib (BAY 73-4506) in Metastatic Gastrointestinal Stromal Tumors (GIST) Meets Primary Endpoint of Improving Progression-Free Survival

Update: Stivarga (regorafenib) Now FDA Approved - September 27, 2012

Wayne, NJ, April 3, 2012 – Bayer HealthCare today announced results from its Phase III trial GRID (GIST – Regorafenib in Progressive Disease) evaluating its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The trial met its primary endpoint of statistically significant improvement in progression-free survival. In this trial, the safety and tolerability of regorafenib were consistent with what was seen in earlier studies. Data from the study are expected to be presented at an upcoming scientific meeting. The GRID study was sponsored by Bayer with academic leadership from the principal investigator George Demetri, M.D., Director of the Ludwig Center at the Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, U.S.A. The study started in January 2011 and completed enrollment by July 2011.

“Additional treatment options are needed for GIST patients after failure of approved drugs,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “These findings may represent potential progress in this difficult-to-treat disease with high unmet patient need.”

Bayer is in ongoing discussions with health authorities worldwide. The company has plans to file for U.S. approval of regorafenib in the treatment of metastatic GIST.

About the GRID Study
GRID (GIST – Regorafenib In Progressive Disease) was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST.[i] It enrolled 199 patients whose disease had progressed despite prior treatment with at least imatinib and sunitinib.1

Patients were randomized in a 2:1 ratio to receive either regorafenib (160 mg once daily, 3 weeks on/1 week off) plus best supportive care (BSC) or placebo plus BSC.1 Subjects receiving placebo who experienced disease progression were offered regorafenib treatment.1 The primary endpoint of this trial is progression-free survival, and secondary endpoints include overall survival, time to progression, disease control rate, tumor response rate, and duration of response.1 In this trial, safety was also evaluated.1

About GIST
GIST is the most common form of sarcoma (a type of cancer that develops from certain tissues, like bone or muscle) involving the gastrointestinal tract.[ii] Targeted therapy may be used to treat GIST tumors if the tumor cannot be surgically removed or to shrink it to become small enough to be removed by surgery.[iii] In the United States, it is estimated that there are approximately 4,000-5,000 new cases of GIST diagnosed each year.[iv] GIST may not cause any symptoms and may be found incidentally when the doctor is looking for other problems.4
About Regorafenib
Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, tumor microenvironment and oncogenic kinases and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Regorafenib is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.

Regorafenib is one of several cancer compounds in Bayer’s development pipeline. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
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Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Media Contact:
Rose Talarico, +1 973 305 5302
Email: rose.talarico@bayer.com


Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
 

Posted: April 2012

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