Phase 2 study of regorafenib for the treatment of renal cell carcinoma (RCC)

Bayer announced results from its Phase 2 trial of regorafenib (BAY 73-4506) for the treatment of patients with metastatic renal cell carcinoma (RCC). This 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 Response Evaluation Criteria in Solid Tumors (RECIST). The secondary end points included safety, progression-free survival, duration of response, duration of stable disease, pharmacokinetics, and biomarker data. Treatment with regorafenib resulted in a 31 percent partial response rate and 50 percent stabilization rate in patients with metastatic renal cell carcinoma (RCC).

Regorafenib is a potent oral multi-kinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases (TK), including inhibition of both VEGFR2 and TIE2 TK. Regorafenib has also been shown in preclinical studies to prevent the proliferation of tumor cell lines while promoting apoptosis (cell death) by directly targeting several oncogenic TK receptors.

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