Phase III trial of Aplidin (plitidepsin) meets endpoint in multiple myeloma- PharmaMar

PharmaMar has announced positive top-line results of its Phase III clinical trial ADMYRE with Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin has shown a statistically significant 35% reduction in the risk of progression or death over the comparator. The study has met its primary endpoint. This pivotal, randomized, open-label, international, multicenter Phase III clinical trial enrolled 255 patients in 83 medical centers across 19 countries (including the U.S, Europe and Asia-Pacific) with relapsed or relapsed and refractory multiple myeloma after at least three but no more than six prior therapeutic regimens.

The efficacy of plitidepsin in combination with dexamethasone versus dexamethasone alone has been evaluated by means of PFS calculated using the IMWG (International Myeloma Working Group) criteria and other secondary efficacy endpoints. A full description of the final ADMYRE data will be submitted for presentation at an upcoming medical meeting.