Adding plitidepsin to dexamethasone significantly reduced the risk of progression or death by 35% as compared with dexamethasone alone in patients with relapsed/refractory multiple myeloma, PharmaMar has announced.1
For the international, open-label, phase 3 ADMYRE trial, researchers enrolled 255 patients with relapsed or relapsed and refractory multiple myeloma after at least 3, but no more than 6, prior treatment regimens. Patients were randomly assigned to receive plitidepsin plus dexamethasone or dexamethasone alone.
The efficacy of the novel agent in combination with dexamethasone vs dexamethasone alone has been evaluated with progression-free survival calculated using the International Myeloma Working Group Criteria and response rate, duration of response, and overall survival as secondary outcomes.
Preliminary results have shown that plitidepsin demonstrated a statistically significant 35% reduction in the risk of disease progression or death (P = .0054), thus meeting the study’s primary endpoint.
Plitidepsin, a first-in-class drug specifically targeting eEF1A2 in tumor cells, is an investigational anticancer agent of marine origin, originally derived from the Aplidium albicans.
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The drug is currently in clinical development for hematological cancers, including this phase 3 trial in relapsed or refractory multiple myeloma, a phase 1b study in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma, and a phase 2 trial in relapsed or refractory angioimmunoblastic T-cell lymphoma.
Plitidepsin has received Orphan Drug Designation by the U.S. Food and Drug Administration.
- Aplidin® shows positive results in pivotal phase III clinical trial for multiple myeloma [news release]. Madrid, Spain: PharmaMar; March 31, 2016. https://www.pharmamar.com/wp-content/uploads/2016/03/PR_Positive-Results_ADMYRE.pdf. Accessed April 4, 2016.