Sutent plus paclitaxel did not improve progression-free survival.

Pfizer’s most advanced cancer program suffered a second blow with the company calling off Phase III trials evaluating Sutent as a first-line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee found that the primary endpoint of superior progression-free survival would not be achieved.

In April, Pfizer stopped a late-stage trial comparing Sutent to standard-of-care in advanced breast cancers citing a similar inability to significantly improve progression-free survival. Even with these first results from a program evaluating a combination therapy not showing an improvement, the firm says that it will continue on its path to evaluate Sutent in various regimens against solid tumors.

Sutent is already approved for gastrointestinal stromal tumors and advanced/metastatic renal cell carcinoma. It is in a slew of mid- to late-stage studies including advanced non-small-cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma, and advanced hormone-refractory prostate cancer.

The latest trial to be stopped was evaluating Sutent plus paclitaxel versus bevacizumab plus paclitaxel. Ongoing Phase III trial investigations in advanced breast cancer include Sutent plus docetaxel versus docetaxel for first-line treatment and another looking at Sutent plus capecitabine versus capecitabine for second-line treatment. Analysis from both is expected by the end of the year or early next year.

Related News

Pfizer Calls Off Late-Stage Evaluations with Anxiety and Fibromyalgia Drugs (Feb. 24, 2009)
Pfizer Halts Phase III Trial with Pancreatic Cancer Drug (Feb. 2, 2009)
Pfizer Pulls the Plug on Late-Stage Obesity Treatment (Nov. 6, 2008)
Pfizer Nixes Phase III Melanoma Trial (Apr. 2, 2008)

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