Pfizer Inc announced the discontinuation of the SUN 1122 Phase 3 trial that evaluated Sutent® (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC). The independent Data Monitoring Committee (DMC) found that the addition of sunitinib to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone, in this study. No new safety issues were identified.
"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," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "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. Pfizer also continues to study sunitinib in late-stage trials as a potential treatment for various other types of cancer."
Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings.
These results do not affect the approved indications with sunitinib as monotherapy, where it has played a significant role in advancing the care of patients. Sunitinib is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced / metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials. To date, over 50,000 patients have been treated globally.
Sunitinib Clinical Research Program
Pfizer Oncology is committed to exploring and delivering innovative therapies to patients with cancer, and is continuing to study the potential role of sunitinib in the treatment of various solid tumors including advanced non-small cell lung cancer, advanced breast cancer, advanced hepatocellular carcinoma and advanced hormone-refractory prostate cancer, in Phase 3 trials.
Healthcare professionals who are interested in learning more about sunitinib trials that are open for enrollment can visit the SUN program web site at www.suntrials.com. Patients with questions should contact their treating physician.
About Colorectal Cancer (CRC)
About 630,000 deaths from CRC were estimated to occur in 2007 worldwide, accounting for eight percent of all cancer deaths. Five-year survival rates for patients with metastatic disease, cancer that has spread to distant parts of the body, such as the liver, are much lower, at 11 percent.
About Sutent® (sunitinib malate)
Sutent is an oral multi-kinase inhibitor approved for the treatment of GIST after disease progression on or intolerance to imatinib mesylate and advanced RCC.
Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important Sutent targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.
For more information on Sutent and Pfizer Oncology, including full prescribing information for Sutent (sunitinib malate), please visit www.pfizer.com.
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