BAY 73-4506 shows 27% partial response rate in RCC

Germany's Bayer AG reported preliminary data at the American Society of Clinical Oncology 2009 meeting, in Orlando, Florida, from a Phase II,  open-label study of BAY 73-4506 in renal cell carcinoma that showed a  27% partial response rate according to the Response Evaluation Criteria  in Solid Tumors and a disease control rate of 79%.

The most common drug-related adverse events were hand-foot skin  reaction, fatigue, hypertension, mucositis, dysphonia, rash, diarrhea  and anorexia. The Phase II study enrolled 49 previously-untreated  patients with predominantly clear cell RCC. BAY 73-4506 (160mg) was  administered once daily on a three weeks on/one week off schedule.

In another presentation at the ASCO meeting, data from the Phase I  dose-finding study in CRC showed the oral multi-kinase inhibitor, dosed  at 160mg daily, using a treatment schedule of 21 days on/seven days off,  was feasible in patients with advanced refractory CRC. Disease control  rate (PR + SD) was 74% in evaluable patients.