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Bayer Submits NDA for Regorafenib for Treatment of Gastrointestinal Stromal Tumors (GIST)
Progression-free survival improved in pivotal trial (Aug. 30)
Bayer HealthCare and Onyx Pharmaceuticals, Inc. announced on August 30 that Bayer has submitted a New Drug Application (NDA) to the FDA for the oral multikinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.
Regorafenib is a Bayer compound. In 2011, the company entered into an agreement with Onyx Pharmaceuticals under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will jointly promote regorafenib in the U.S.
The NDA submission was based on data from the pivotal phase III GRID (GIST — Regorafenib In Progressive Disease) trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared with placebo plus BSC (hazard ratio [HR]: 0.27; P < 0.0001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm, and there was a positive trend in the regorafenib group in improving overall survival (OS) (HR: 0.77; P = 0.20).
The most frequently reported drug-related adverse events in regorafenib-treated patients versus placebo-treated patients, respectively, were hand–foot skin reactions (56.1% vs.13.6%), hypertension (48.5% vs. 16.7%), diarrhea (40.2% vs.4.5%), fatigue (38.6% vs. 27.3%), and oral mucositis (37.9% vs. 7.6%).
Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June.
For more information, visit the Onyx Pharmaceuticals Web site.
