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The independent Data Monitoring Committee 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 compared to FOLFIRI alone. There were no new safety issues identified.
Pfizer, however, said it would pursue the study of sunitinib in late stage trials as a potential treatment for various other types of cancer.
Commenting on the result, 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."
Earlier, the company discontinued a late-stage trial of Sutent or sunitinib malate plus paclitaxel versus bevacizumab plus paclitaxel as a first line treatment of patients with advanced breast cancer.
Sutent or sunitinib malate is an oral multi-kinase inhibitor approved for gastrointestinal stromal tumor after disease progression upon intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.
Sunitinib is currently approved for both gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma based on efficacy and safety data from large, randomized Phase 3 clinical trials. To date, over 50,000 patients have been treated globally.
Pfizer said it has notified clinical trial investigators and regulatory agencies involved in the study about the findings. The results, however, do not affect the approved indications with sunitinib as monotherapy, the company said.
The most common adverse reactions in advanced metastatic renal cell carcinoma and gastrointestinal stromal tumor clinical trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.
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. Investigators will be consulted about the status of sunitinib colorectal studies other than the SUN 1122 trial."
PFE closed Wednesday's regular trading at $15.00, down $0.26 or 1.70%, on a volume of 52.10 million shares. In after-hours, the stock further dropped $0.10 or 0.67%, to trade at $14.90. In the last 52-week period, the stock traded in the range of $11.62 to $20.13, with a three-month average volume of 57.12 million shares.
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