Pfizer has signed on Debiopharm Group to evaluate its melanoma drug candidate tremelimumab, which previously failed in Phase III. The companies’ co-development agreement for tremelimumab has Debiopharm responsible for the trial, while Pfizer retains rights to worldwide commercialization.
An interim analysis done on tremelimumab, a fully human anti-CTLA4 mAb, during its last Phase III development program found that it would not offer any benefit over standard chemotherapy. Thus in April 2008, Pfizer was forced to halt the trial.
A full evaluation of the data revealed a biomarker that predicted patients who were more likely to respond. The Phase III study to be conducted by Debiopharm will leverage this marker to select patients with unresectable, stage IV melanoma for enrollment.