Pfizer halts Sutent head-to-head trial
pharmafile | April 6, 2009 | News story | Research and Development, Sales and Marketing | Cancer, Pfizer, Sutent
Pfizer has halted a late-stage breast cancer trial between Sutent and Roche's Xeloda, after the study failed to show significant improvement of progression-free survival in patients.
Pfizer's Sutent is approved in two other indications and has made the company a contender in oncology or the first time, but its failure to perform in breast cancer is a blow for the company.
The now discontinued phase III trial evaluated the two drugs for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment.
It was found that even if the trial had continued, treatment with single-agent Sutent would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to single-agent Xeloda in the study population.
Dr Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's oncology business unit, said: "We are disappointed with these results given the previous findings that suggested [Sutent] may provide benefit for patients with this difficult-to-treat cancer."
Sutent (sunitinib) is currently approved to treat advanced kidney cancer and gastrointestinal stromal tumour in patients who fail to respond to Novartis' Glivec or are intolerant to it.
Pfizer says it remains committed to further developing the drug, which is also being studied in phase III trials as a treatment for cancers of the liver, colon and prostate, as well as for non-small cell lung cancer.
Rothenberg said: "In ongoing studies, we remain committed to evaluating [Sutent] in advanced breast cancer and are continuing to study sunitinib in different populations and with different regimens."
Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings, and is encouraging investigators to determine the best course of action for their individual patients.
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