Date: 2016-03-31
Type of information: Results
phase: 3
Announcement: results
Company: PharmaMar (Spain)
Product: Aplidin® (plitidepsin) in combination with dexamethasone
Action
mechanism: depsipeptide derivative. 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 EMA and the FDA.
Disease: relapsed/refractory multiple myeloma
Therapeutic area: Cancer - Oncology - Rare diseases
Country: Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Republic of Korea, The Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Spain, Taiwan, UK, USA
Trial
details: This pivotal, randomized, open-label, international, multicenter Phase III clinical trial, called ADMYRE will compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles). The trial enrolled 255 patients in 83 medical centers across 19 countries with relapsed or relapsed and refractory multiple myeloma after at least three but no more than six prior therapeutic regimens.(NCT01102426)
Latest
news: * On March 31, 2016, PharmaMar announced 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. 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. 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 * On June 1, 2015, PharmaMar announced that the company has completed patient recruitment of Phase III registration trial (ADMYRE) with Aplidin® (plitidepsin) in multiple myeloma. This pivotal study will assess the efficacy of plitidepsin plus dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
endpoints. A full description of the final ADMYRE data will be submitted for presentation at an upcoming medical meeting.
