Pfizer halts Sutent colon cancer trial
pharmafile | July 2, 2009 | News story | Research and Development, Sales and Marketing | Cancer, Pfizer, Sutent
Pfizer has halted a phase III trial for its oncology hope Sutent, after it failed to show significant improvement in patients with advanced colorectal cancer.
The drug is approved in two other indications and has made the company a contender in oncology for the first time, but its failure to perform in the new indication marks a blow for Pfizer.
Dr Mace Rothenberg, the company's senior vice president of clinical development and medical affairs in oncology, said: "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."
Sutent works by blocking multiple molecular targets implicated in the growth and spread of cancer. To date, more than 50,000 patients have been treated globally with Sutent (sunitinib). It 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.
The discontinued trial was evaluating Sutent plus Folfiri, a standard chemotherapy regimen, compared to Folfiri alone, for the first-line treatment of advanced colorectal cancer.
The independent Data Monitoring Committee found that the addition of Sutent to Folfiri was unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival.
Pfizer has notified the trial investigators and regulatory agencies of the findings, and said it will consult with them about the status of Sutent in other colorectal studies.
The company says the results do not affect the approved indications for Sutent as a monotherapy, and that it will continue to pursue the drug as a treatment for other types of cancer.
Rothenberg added: "Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline."
This is not the only bad news Pfizer has received this year. It recently halted another late-stage trial for Sutent in breast cancer. In a trial comparing the drug to Roche's Xeloda Sutent failed to show significant improvement of progression-free survival in patients.
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