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Pfizer Inc has announced the Phase III clinical trial (A3671009), of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma has been discontinued.
The decision comes after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.
Pfizer has informed worldwide regulatory authorities and investigators regarding the discontinuation of the trial. Investigators will now work with their patients to determine if they are benefiting from treatment and therefore should continue treatment with tremelimumab.
Patients are being encouraged to contact their physician with questions about their treatment.
“Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high risk area of research with significant unmet medical need. We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer,” said Charles Baum, MD, PhD, Vice President and Oncology Therapeutic Area Head at Pfizer Global Research and Development.
“We will continue to assess the study data to understand the clinical benefit seen in some patients who received tremelimumab.”
The full data set from study A3671009 is being analysed, and more details are expected to be available at the upcoming American Society for Clinical Oncology Annual Meeting in June 2008.
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