Multiple Myeloma Drug Shows Positive Results in Phase 3 Trial
Plitidepsin (Aplidin) in combination with dexamethasone shows 35% reduction in the risk of progression or death over comparator drug in multiple myeloma.
A pivotal phase 3 clinical trial showed positive results from an investigational anti-cancer agent for relapsed or refractory multiple myeloma (MM).
The randomized open-label, multicenter trial ADMYRE enrolled 255 patients to test the safety and efficacy of plitidepsin (Aplidin) in combination with dexamethasone.
Participants were recruited from 83 medical centers across 19 countries with relapsed or refractory MM after a minimum of 3, but no more than 6, previous therapeutic regimens.
The results of the study showed statistical significance, with a 35% reduction in the risk of progression or death over the comparator (p=0.0054).
“Taking into account these positive results, we intend to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year,” said Luis Mora, managing director of the Oncology Business Unit of PharmaMar. “I’d like to thank all the patients, physicians and the dedicated team at PharmaMar who helped participate in the success of this trial. Aplidin may be our second drug of marine origin in the market.”