Genentech Inc. has announced that an interim analysis shows that a randomised phase III clinical study of Avastin (bevacizumab) in combination with interferon alfa-2a therapy in patients with first-line metastatic renal cell carcinoma (mRCC) met the primary analysis endpoint by significantly improving progression-free survival (PFS) compared to interferon alfa-2a therapy alone.
In addition, the early analysis indicates a trend toward improvement in overall survival in the Avastin plus interferon arm. An independent data safety monitoring board (DSMB) has recommended that patients in the study be made aware of the results and offered treatment with Avastin. results from the study will be submitted for presentation at an upcoming medical meeting.
RCC is the most common type of kidney cancer, accounting for nine out of 10 cases, and new treatment options are needed, as fewer than 10 per cent of late-stage kidney cancer patients will live five years following diagnosis. According to the American Cancer Society, there will be 38,890 new cases of kidney cancer and 12,840 kidney cancer deaths in 2006.
''We are pleased with the results demonstrating improvement in progression-free survival in this study and plan to discuss the data and the submission of an application for a potential indication in renal cell cancer with the US Food and Drug Administration,'' said Hal Barron, MD, Genentech's senior vice president, Development and chief medical officer.
These results reinforce our belief that inhibiting angiogenesis by specifically blocking vascular endothelial growth factor could provide important clinical benefit across a broad range of tumour types.'' Adverse events in this study appeared to be similar to those previously reported for interferon and for Avastin. The most common adverse events that occurred more often in the Avastin plus interferon arm included bleeding, hypertension and proteinuria.