Medarex and Bristol-Myers Squibb report mixed melanoma data

The results from study 008, conducted under special protocol assessment (SPA), did not meet the primary endpoint, which was to rule out a best objective response rate of less than 10%. However, the totality of data from the registrational program included a clear dose response effect observed in study 022 and best objective response rates across the three studies ranging from mid-single digits to mid-teens as determined by independent radiology review.

The objective responses were consistent with previous observations and included complete and partial responses. The majority of the responses were ongoing at the end of the observation period. In contrast to standard cytotoxic therapy, responses at the highest doses were noted to evolve over time; these patterns of response appear potentially unique to this form of therapy.

Medarex and Bristol-Myers Squibb are planning to submit a regulatory filing to the FDA in the first half of 2008.