PharmaMar announced top-line data from its Phase 3 ADMYRE clinical trial with Aplidin (plitidepsin) in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM).
ADMYRE was a randomized, open-label, international multicenter Phase 3 trial (N=255) that enrolled patients with relapsed or relapsed and refractory MM after at least 3 but no more than 6 prior therapeutic regimens. Treatment with Aplidin showed a statistically significant 35% reduction in the risk of progression or death vs. the comparator arm (P=0.0054).
The efficacy of plitidepsin by means of progression-free survival was calculated using the International Myeloma Working Group (IMWG) criteria and other secondary efficacy endpoints. Final ADMYRE data will be submitted for presentation at an upcoming medical meeting.
Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It is a first-in-class drug specifically targeting eEF1A2 in tumor cells. It has received orphan drug designation from the Food and Drug Administration (FDA).
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