Pivotal trial demonstrates almost double survival rate in multiple myeloma

PharmaMar has presented positive results from the ADMYRE Phase III pivotal trial of Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed or relapsed and refractory multiple myeloma. As previously informed, the Phase III trial, ADMYRE, which compared plitidepsin in combination with dexamethasone versus dexamethasone alone met its primary endpoint, progression free survival, and secondary objectives, overall survival and safety. With regards to the primary endpoint, in patients who received the combination of plitidepsin with dexamethasone, a 3.8 month progression free survival (PFS) was observed in comparison to 1.9 months with dexamethasone alone, according to the investigator´s assessment.

With respect to overall survival, all patients obtained an overall survival that almost doubled the comparative with dexamethasone (11.6 months versus 6.4 months). In patients that experimented stable disease (65%), overall survival was 17 months. With reference to safety, PharmaMar presented a comparative table on adverse events in which plitidepsin was shown to be better tolerated than other drugs already used for multiple myeloma. Quality of Life evolution, this being evaluated according to a deterioration in the performance status, was better in patients treated with the combination of plitidepsin plus dexamethasone.

A novel mechanism of action was also presented, demonstrating that plitidepsin is complimentary to actual treatments. Plitidepsin reduces the number of osteoclasts and inhibits its function. Osteoclasts are the cells responsible for bone destruction in multiple myeloma. This data, from a preclinical study, were also presented during ASH ((poster #3065). The data were presented at the 59th American Society of Hematology annual Meeting.