In a positive development, Bayer (BAYRY.PK) released encouraging results from a phase II trial of regorafenib in patients with metastatic renal cell carcinoma (RCC), a type of kidney cancer. The phase II trial was carried out on 49 previously untreated patients whose tumors could not be removed surgically or had started spreading.
The trial met its primary endpoint, which was to evaluate response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST). It was observed that 31% of patients experienced a confirmed partial response (PR) whereas 50% of patients experienced stable disease (SD). In addition, the data showed an estimated median progression-free survival of 8.3 months.
The 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) at Berlin . The promising results of regorafenib show its potential as a first-line treatment option for patients with advanced RCC. Following encouraging results, Bayer intends to begin phase III trials of the drug.
Earlier in May 2009, Onyx Pharmaceuticals (ONXX) sued Bayer regarding the rights to regorafenib. Both the companies co-developed Nexavar, for the treatment of liver cancer and advanced kidney cancer.
With the molecular structure of both the drugs being similar except for one atom, Onyx filed a complaint claiming its right to the drug. It alleges that the drug should be treated under the collaboration agreement while Bayer claims its sole rights.
Nexavar is one of Bayer’s new drugs with huge potential which recorded sales of €147 million during the second quarter, up by 36%. Following positive results of regorafenib, stakes are quite high for both the companies.
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