Pfizer says clinical trials for Sutent did not meet expectations; halts additional cancer treatment study

NEW YORK Two clinical trials of a Pfizer drug for treating advanced breast cancer have failed, Pfizer announced Thursday.

The world’s largest drug maker said two phase 3 trials in which Sutent (sunitinib malate) was added to chemotherapy did not extend patients’ lives while preventing their disease from progressing compared with chemotherapy alone. The SUN 1064 trial combined Sutent with docetaxel chemotherapy, while the SUN 1099 trial combined it with capecitabine.

Sutent is currently approved for treating gastrointestinal stromal tumor in patients whose disease has progressed after taking or who are unable to take Novartis’ Gleevec (imatinib mesylate) and kidney cancer. Pfizer is also studying the drug as a possible treatment for lung cancer, prostate cancer and liver cancer.

On the same day it announced the Sutent results, Pfizer also halted a phase 3 study of Genentech’s and OSI Pharmaceuticals’ Tarceva (erlotinib) combined with CP-751,871 (figitumumab) in patients with non-adenocarcinoma non-small cell lung cancer. An independent monitoring committee recommended that the trial be stopped when it found that adding the two drugs together was not likely to yield more effective treatment than Tarceva alone.

“This outcome is disappointing to us and to patients with NSCLC,” Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said in a statement.

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