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July 1, 2009

Another Sutent Trial Bites the Dust for Pfizer

  • Another late-stage trial with Pfizer’s Sutent® has been called off. This time an evaluation of Sutent plus Folfiri versus Folfiri alone as a first-line treatment of metastatic colorectal cancer (CRC) found that a statistically significant improvement in the primary endpoint of progression-free survival (PFS) would not be achieved.

    Pfizer has already had to stop two Phase III trials investigating Sutent alone and along with paclitaxel in advanced breast cancer. Most recently, though, the firm reported that Sutent improved PFS for those with advanced pancreatic islet cell tumors.

    “We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care,” says Mace Rothenberg, M.D., svp of clinical development and medical affairs for Pfizer’s oncology business unit.

    Sutent is an oral multikinase inhibitor approved for gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. It is also sanctioned for the treatment of advanced/metastatic renal cell carcinoma.

    Sutent continues to be studied in various solid tumors including advanced non-small-cell lung cancer, advanced breast cancer, advanced hepatocellular carcinoma, and advanced hormone-refractory prostate cancer.


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