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Bayer's Novel Anti-Cancer Compound Regorafenib (BAY 73-4506) Showed Stabilization or Regression in 81 Percent of Kidney Cancer Patients
Date:9/22/2009

s, 25 patients remained on treatment and 80 percent (12 of 15) of patients who achieved a PR had an ongoing response. Two additional patients who were classified as having SD achieved a confirmed PR past the data analysis date, bringing the total PR to 35 percent (n=17) of patients. Study data continue to be reviewed.

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."

About the Trial

This Phase II, multicenter, open-label, single-arm study of regorafenib enrolled 49 previously untreated patients with metastatic or unresectable, predominantly clear-cell RCC. Regorafenib (160 mg) was administered once daily on a three weeks on/one week off schedule. The primary end point was to evaluate response rate according to RECIST. The secondary end points included safety, progression-free survival, duration of response, duration of stable disease, pharmacokinetics, and biomarker data.

About Regorafenib (BAY 73-4506)

Regorafenib (BAY 73-4506) is a potent oral multi-kinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). The distinct anti-angiogenic profile includes inhibition of both VEGFR2 and TIE2 TK. Regorafenib has also been shown in preclinical studies to p
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SOURCE Bayer HealthCare
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