Investigational targeted therapy extends RCC progression-free survival

The investigational agent axitinib (AG-013736) appears to significantly extend progression-free survival compared with sorafenib (Nexavar) in patients with previously treated advanced renal cell carcinoma, according to a study presented at the American Society of Clinical Oncology annual meeting in Chicago.

Progression-free survival was significantly longer in axitinib-treated patients compared with those treated with sorafenib, regardless of prior therapy with sunitinib malate (Sutent) or cytokines.

In this global study, which included centers in the U.S., Europe, and Japan, 723 patients with clear-cell advanced RCC who had progressed following prior therapy were enrolled. Participants received either axitinib at a starting dose of 5 mg twice daily or sorafenib, 400 mg twice daily.

Progression-free survival was statistically significantly longer in axitinib-treated patients in both the prior cytokine-treated subgroup (12.1 vs. 6.5 months; pp=.0107), with a 43% improvement in median progression-free survival in the overall patient population, compared with sorafenib. In a secondary endpoint, objective response rates were more than doubled with axitinib compared with sorafenib in the overall patient population (19.4% vs. 9.4%, p=.0001).

"These data, from the first head-to-head phase III study comparing active targeted therapies in advanced RCC, are important for clinicians as they help us advance our understanding of this tumor, where there are limited proven options for previously treated patients," said principal investigator Brian I. Rini, MD, of Cleveland Clinic’s Taussig Cancer Institute. "The clinically meaningful improvement in progression-free survival seen with axitinib is even more encouraging as it was accompanied by generally manageable tolerability, an important consideration for these patients."

The trial was sponsored by Pfizer, Inc., for whom Dr. Rini has been a paid consultant.