Phase III Data on Bayer's Regorafenib Met Primary Endpoint Showing Significant Improvement in Progression-Free Survival in Patients with GIST
WAYNE, N.J., June 4, 2012 /PRNewswire/ -- Bayer HealthCare today announced data from the Phase III GRID (GIST – Regorafenib In Progressive Disease) trial evaluating its investigational drug regorafenib in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib. The GRID study met its primary endpoint of improvement in progression-free survival (PFS) (HR=0.27, p<0.0001).(1) The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm.(1) These data will be presented as a late-breaking abstract in an oral abstract session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL (USA) (LBA No. 10008).
"GIST continues to represent an area of unmet patient need, given the aggressive nature of the disease and our limited therapeutic options," said George Demetri, M.D., Director, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Chair of the Steering Committee for the GRID trial. "These data from the GRID study indicate that regorafenib may be a potential treatment option for patients who have relapsed after standard therapies."
The most common drug-related, treatment-emergent adverse events (occurring in at least 10% of patients during double-blind treatment) included hand-foot skin reaction (56.1% vs.15.2%), hypertension (48.5% vs. 16.7%), diarrhea (40.9% vs.7.6%), fatigue (38.6% vs. 27.3%), oral mucositis (37.9% vs. 9.1%), alopecia (23.5% vs. 3.0%), hoarseness (22.0% vs. 4.5%), anorexia (20.5% vs. 7.6%), rash, maculopapular (18.2% vs. 3.0%), nausea (15.9% vs. 9.1%), constipation (15.2% vs. 7.6%), myalgia (13.6% vs. 9.1%), and voice alteration (11.4% vs. 3.0%) for patients receiving regorafenib as compared to placebo.(1)
"We are pleased to present the data from the Phase III GRID trial," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "These data reinforce the need to explore the potential of regorafenib as a treatment for patients with metastatic and/or unresectable GIST who have exhausted available therapies and urgently need new options."
Bayer has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC). Bayer plans to submit a New Drug Application for regorafenib in GIST in the second half of 2012.
About the GRID Trial
GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST.(1) It enrolled 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib.(1) Patients were randomized in a 2:1 ratio to receive either regorafenib (160 mg once daily, three weeks on/ one week off) plus best supportive care (BSC) or placebo plus BSC to evaluate efficacy and safety.(1) The primary endpoint of this trial was PFS, and secondary endpoints included overall survival, time to progression, disease control rate, tumor response rate, and duration of response.(2)
Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.(2)
Regorafenib is an investigational agent and is not approved by the FDA, 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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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.
Demetri, et al. Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU): GRID trial [Presentation]. 2012 American Society of Clinical Oncology; June 1-5, 2012. Chicago, IL.
Bayer Healthcare. A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatments with at least imatinib and sunitinib [Integrated Clinical Study Protocol]. September 27, 2011.
SOURCE Bayer HealthCare