PharmaMar (MSE:PHM) today 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 (p=0.0054). The study has met its primary endpoint.
This pivotal, randomized, open-label, international, multicenter Phase III clinical trial, called ADMYRE, 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.
"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, who added "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".
As previously disclosed PharmaMar has entered into licensing agreements to market and distribute the drug candidate Aplidin with Specialised Therapeutics Asia, covering several Asian countries, Australia and New Zealand; with TTY Biopharm in Taiwan; and with a co-promotion agreement in 8 European countries with Chugai Pharma Europe.