Researchers involved in an international randomized Phase II clinical trial have reported that Recentin™ (cediranib), a potent inhibitor of vascular endothelial growth factor (VEGF) tyrosine kinases, is active for the treatment of patients with advanced renal cell carcinoma (RCC). The details of this study were presented as a late-breaking abstract at the Joint ECCO 15 – 34^th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009.[1]

Recentin is a pan-vascular endothelial growth factor receptor (VEGFR) inhibitor that has shown significant activity in patients with refractory breast cancer. Researchers from the Massachusetts General Hospital, the National Cancer Institute, and the Dana Farber Cancer Center have reported that Recentin appears to prolong survival among patients with recurrent glioblastoma multiforme (GBM).[2] A Phase I study has shown that Recentin can be combined safely with promising results with Platinol® (cisplatin) and Gemzar® (gemcitabine) for the treatment of patients with advanced non–small cell lung cancer.[3] A Phase I study has also shown that Recentin can be added to Eloxatin® (oxaliplatin) and infusional 5-Fu for the treatment of patients with advanced colorectal cancer.[4] A Phase III trial comparing Recentin and FOLFOX versus Avastin® (becacizumab) for first-line treatment of metastatic colorectal cancer is planned.[5] Recentin has also shown activity in patients with acute myeloid leukemia (AML).[6]

The current study involved 53 patients with metastatic or recurrent RCC randomly allocated to treatment with Recentin and 18 allocated to receive placebo. The average tumor size at six weeks had decreased by 20% in the Recentin group, while the average tumor size had increased by 20% in the placebo group. Maximum tumor reduction following Recentin treatment was 31%. Ten of 14 patients in the control group who subsequently received Recentin had significant tumor reduction. The ultimate partial response rate was 34%, and 47% experienced stable disease for a disease control rate of 81%. Progression-free survival was prolonged from 2.7 months to 12.1 months with the use of Recentin.

Comments: These data suggest that Recentin can be added to the growing list of targeted agents effective in RCC. The most interesting future study will be the head-to-head comparison of Recentin with Avastin for the initial treatment of colorectal cancer. The observation that AML patients responded to Recentin is also of great interest.

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