Phase 3 study of Sutent discontinued for metastatic colon cancer

Pfizer announced the discontinuation of the SUN 1122 Phase 3 trial evaluating Sutent (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI monotherapy for the first-line treatment of metastatic colorectal cancer (CRC). The independent Data Monitoring Committee (DMC) found that the addition of sunitinib to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone, in this study.

Sutent is an oral multi-kinase inhibitor approved for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate and advanced / metastatic renal cell carcinoma (RCC).

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