Keywords: Pfizer, Debiopharma, Tremelimumab, Melanoma, Research

Pfizer revives development of tremelimumab for advanced melanoma in deal with Debiopharm

Article | 8 January 2010

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Having in April 2008 dropped a late-stage trial of the skin cancer drug, US pharmaceutical leviathan Pfizer has entered into a co-development agreement with Switzerland’s Debiopharm to conduct a Phase III trial of tremelimumab (CP675,206), a fully-human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma. This time, a biomarker will be used to select patients considered likely to respond to tremelimumab.

Under the terms of the agreement, financial terms of which were not disclosed, Debiopharm will assume responsibility for conducting the Phase III study of tremelimumab and Pfizer will retain responsibility for worldwide commercialization of the compound.

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Pfizer’s tremelimumab development in melanoma was halted after the Data Safety Monitoring Board review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy in this indication. Studies in other tumors, such as prostate and bladder cancer, continued. Analysis of the data from the original study identified the biomarker which will be used in patient selection for the upcoming trial.

“The continuation of the clinical development of tremelimumab with our partner, Debiopharm, is a demonstration of our commitment to personalized medicine for cancer patients,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit. “Debiopharm is a successful company which has achieved impressive results on a global scale. This co-development partnership is an opportunity to leverage the combined expertise of both companies in this innovative endeavor,” he added.

Melanoma, the deadliest form of skin cancer, occurs in about 69,000 patients in the USA each year, and results in about 9,000 deaths. The number of melanoma cases worldwide is increasing faster than any other cancer, the drug giant noted.