Pfizer announced yesterday, June 30, 2009, that they are discontinuing a phase III trial comparing FOLFIRI chemotherapy alone to FOLFIRI with added Sutent® (sunitinib).
Based on results so far, the independent Data Monitoring Committee (DMC) determined that a significant reduction in progression-free survival was not statistically possible. No new safety concerns were identified.
Pfizer was conducting SUN 1122 in a number of countries worldwide.
The primary goal of the trial was to show that Sutent could increase the time it took for cancer to get worse (progression-free survival). Patients in the trial were having their first treatment for advanced colorectal cancer.
Treatment was either FOLFIRI (irinotecan, leucovorin, and continuous infusion 5-FU) alone or FOLFIRI with additional Sutent.
While research teams, doctors, and patients on a clinical trial don’t know the results until after the study is complete and analyzed, trials have an independent Data Monitoring Committee that reviews safety and emerging results regularly. Sometimes DMCs will decide that a trial should be ended early, either because data is so strong for effectiveness that everyone on the trial should have access to the experimental treatment or — as in this case — that continuing it any longer would not prove that the new treatment helped.
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit 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. Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline. Investigators will be consulted about the status of sunitinib colorectal studies other than the SUN 1122 trial.
Sutent is currently approved by the FDA to treat gastrointestinal stromal tumor (GIST) and metastatic renal cell cancer.