PharmaMar has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of Aplidin (plitidepsin) in combination with Decadron (dexamethasone, an anti-inflammatory drug) for the treatment of relapsed/refractory multiple myeloma patients. The EMA’s decision is expected by the second half of 2017.
The application was supported by promising results obtained in the ADMYRE Phase 3 trial (NCT01102426), designed to investigate the safety and effectiveness of Aplidin in combination with Decadron, compared to Decadron alone.
This randomized, multicenter, open-label study included 255 patients with relapsed or refractory multiple myeloma, recruited from more than 80 medical centers in 19 countries, including the U.S. These patients had at least three, but no more than six, prior therapeutic regimens to treat their disease.
The effectiveness of Aplidin plus Decadron versus Decadron alone was assessed by the measurement of the progression-free survival (PFS), the study’s primary outcome. Secondary outcomes included response rate, duration of response (DR) and overall survival (OS).
The results obtained indicated that the combination therapy induced a statistically significant reduction (35 percent) in the risk of progression or death compared to Decadron alone, meeting the study’s primary endpoint.
“We have achieved positive results with this molecule throughout its clinical development and we believe Aplidin could become a novel therapeutic alternative for patients with multiple myeloma,” Luis Mora, managing director of the Oncology Business Unit of PharmaMar, said in a news release.
Aplidin is an experimental anticancer drug originally obtained from the marine invertebrate Aplidium albicans. By binding to the eEF1A2 protein, which is involved in protein synthesis, Aplidin causes the inhibition of this process in tumors, leading to cell death.
This drug is also being tested as a potential treatment for blood cancers. Aplidin is currently undergoing evaluation in a Phase 1b clinical trial testing its effect in combination with Velcade (bortezomib) and Decadron in relapsed or refractory multiple myeloma, and in a Phase 2 trial in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma.
Aplidin has already received orphan drug designation (a status granted to drugs to treat rare diseases) by both the U.S. Food and Drug Administration (FDA) and the European Commission.