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ARTICLE | Clinical News

PharmaMar reports OS data from Phase III of Aplidin for MM

January 12, 2018 6:21 PM UTC

PharmaMar S.A. (Madrid:PHM) reported data for the secondary overall survival (OS) endpoint from the Phase III ADMYRE trial in 255 patients with relapsed or refractory multiple myeloma (MM) evaluating Aplidin plitidepsin plus dexamethasone vs. dexamethasone alone. Aplidin plus dexamethasone non-significantly improved median OS vs. dexamethasone alone (11.6 vs. 8.9 months, p=0.1273).

According to the trial protocol, patients were allowed to crossover from the the dexamethasone alone arm to the Aplidin arm after disease progression and after a minimum of eight weeks after randomization. A sensitivity analysis factoring in the 37 patients from the control arm who crossed over to the Aplidin arm showed that Aplidin plus dexamethasone significantly improved median OS vs. dexamethasone alone (11.6 vs. 6.4 months, p=0.0015). Data were presented at the American Society of Hematology meeting in Atlanta in December...