Bayer today announced results from a Phase II trial of regorafenib (BAY 73-4506), a potent oral multi-kinase inhibitor, which demonstrated that treatment with regorafenib resulted in a 31 percent partial response rate and 50 percent stabilization rate in patients with metastatic renal cell carcinoma (RCC). These data were presented in an oral session at the joint 15th Congress of the European CanCer Organisation and 34th Congress of the European Society for Medical Oncology (ECCO 15 - 34th ESMO). Preliminary results from this study were presented earlier this year at the 45th American Society of Clinical Oncology (ASCO) Annual Congress, May 29 - Jun 2, 2009, Orlando, Florida.
"Bayer is committed to researching and developing potential anti-cancer agents like regorafenib, which may eventually help physicians and patients manage this devastating disease," said Kemal Malik, MD, Member of the Board of Management of Bayer Schering Pharma AG and Head of Global Development. "We look forward to continuing the comprehensive clinical development program for regorafenib, which we believe could potentially represent a promising new treatment option for various tumor types."
At the time of data analysis, 81 percent of patients>
The most common drug-related adverse events (all grades) were hand-foot skin reaction (HFSR), fatigue, hypertension, mucositis, diarrhea, alopecia, rash, voice changes, anorexia, nausea, constipation and vomiting.
"This study suggests encouraging activity of regorafenib as a potential first-line treatment option for patients with advanced RCC. These results, coupled with those from Phase I studies in other tumor types, provide rationale for further testing," said lead investigator Professor Tim Eisen, F.R.C.P., PhD, of Addenbrooke's Hospital at the University of Cambridge, UK. "I am excited about the potential of this compound becoming a potential treatment option for patients and physicians."