Pfizer Discontinues Sunitinib Plus Paclitaxel Trial

Published: 02-Jun-2009

Pfizer continues to evaluate sunitinib through two other Phase-III clinical trials

Pfizer has discontinued the SUN 1094 phase III trial of Sutent (sunitinib malate) plus paclitaxel vs. bevacizumab plus paclitaxel, for the first line treatment of patients with advanced breast cancer.

The company said that independent Data Monitoring Committee (DMC) has found that treatment with sunitinib, in combination with paclitaxel, would be unable to meet the primary endpoint of superior progression-free survival (PFS) compared to the combination of bevacizumab and paclitaxel, though no safety issues were identified.

Pfizer has notified clinical trial investigators and regulatory agencies of these findings.

Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs for Oncology Business Unit at Pfizer, said: “While we are disappointed that this trial did not meet its primary endpoint, we are continuing to study sunitinib in different breast cancer populations and with different regimens. Pfizer remains committed to evaluating sunitinib in advanced breast cancer through its two other Phase 3 clinical trials investigating the effectiveness of Sutent in combination with standard of care chemotherapies.”

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