PharmaMar, one of the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs, announced that the patient recruitment for the pivotal phase III trial of Aplidin (plitidepsin) for the treatment of multiple myeloma, denominated ADMYRE, has been successfully completed.
The study, which originally planned to include 250 patients, has enrolled 255 patients in 71 medical centers worldwide, including the US, Europe, Asia, South America, Australia, and New Zealand. An application for marketing authorization in Europe is planned to be submitted in 2016.
ADMYRE is a prospective, pivotal, randomized (2:1), open-label, multicenter study that compares plitidepsin in combination with dexamethasone versus dexamethasone alone in patients who have relapsed or refractory multiple myeloma after at least three prior therapies, but no more than six. Patients must have previously received bortezomib and lenalidomide. In an interim analysis, the Independent Data Monitoring Committee (IDMC) recommended completion of the phase III ADMYRE unmodified given that no safety issues were reported and the study comfortably met the established efficacy threshold upon evaluation of data from 60 evaluable patients.
In this registration trial, the primary endpoint is progression-free survival (PFS), which will be used to compare the efficacy of plitidepsin plus dexamethasone versus dexamethasone alone. Secondary endpoints will evaluate tumor response rate, duration of response and overall survival.
“Our compound represents a first-in-class drug in the therapeutic paradigm of multiple myeloma” said José María Fdez. Sousa-Faro, chairman of PharmaMar. “We are on track now to bring this innovative therapeutic advance a step closer to these patients.”
Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the tunicate Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a phase III study in relapsed or refractory multiple myeloma, a phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drud Administration (FDA).