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April 8, 2008

Pfizer adds to the list of late stage melanoma drug failures

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Eric Whitman, MD, Medical Director, Office of Grants and Research, Atlantic Health System IncEric Whitman, MD 
Medical Director, Office of Grants and Research, Atlantic Health System Inc
Implications: The failure of this study has wide ranging implications for Pfizer and other melanoma trials. This drug, which only a few years ago caused much excitement in the melanoma oncology community, failed to show any survival benefit in this Phase III trial, when compared to standard, but generally ineffective, chemotherapy. Its failure casts a shadow over its sister drug's development by Medarex and BMS, which has already itself disappointed in a different population, second line patients. This was Pfizer's first recent effort in melanoma therapy, and I wonder if it will step back from that field for some time. Also, it raises the question if big pharma companies will continue to try Phase III trials in "tougher" cancers or if they will only invest in biotechs pending the results of the trials before committing to full licensure.

Analysis: The only data that has been released on this trial are overall survival. The full analysis including response rates and progression free survival (ie secondary endpoints) has not yet been published or presented publicly. Presumably this will be at ASCO in May/June.

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