Plitidepsin (Aplidin) in combination with dexamethasone significantly reduced the risk of progression or death for patients with relapsed or relapsed and refractory multiple myeloma, compared with patients treated with dexamethasone only, in a phase 3 clinical trial.1
The National Cancer Institute estimates that there will be 30 330 new cases of multiple myeloma in 2016, representing 1.8% of all new cancer cases, and 12 650 deaths due to multiple myeloma, representing 2.1% of all cancer deaths.2
The phase 3 ADMYRE (Aplidin-Dexamethasone in Relapsed/Refractory Myeloma) trial followed previous phase 2 and 3 studies that evaluated the efficacy of treating patients with relapsed and refractory multiple myeloma using plitidepsin only. Dexamethasone was the standard treatment for this patient population when the trial was designed.
“The multiple myeloma patient population is heavily pretreated, and there is no other therapeutic alternative,” the principal investigator, María Victoria Mateos, MD, PhD, of the University Hospital of Salamanca in Spain, told Cancer Therapy Advisor.
“We realize that the standard treatment paradigm for myeloma patients is dramatically changing, but this combination would represent 1 option of therapy for patients who had already received the conventional combinations,” said Dr Mateos. “Subanalysis of this trial will contribute to our knowledge of the specific subgroups of patients who might actually obtain a benefit from this combination.”
ADMYRE enrolled 255 patients from 83 medical centers in 19 countries who had relapsed or relapsed and refractory MM following at least 3 but no more than 6 previous therapeutic regimens. They found a 35% reduction in the risk of progression or death in patients treated with the combination of plitidepsin and dexamethasone over those treated with dexamethasone only. The research team will present the full results at an upcoming medical meeting.
“After the ADMYRE trial, the clinical research with plitidepsin will continue,” said Dr Mateos. “These results will be the starting point for further clinical trials based on plitidepsin.”
Following the announcement of the trial’s results, PharmaMar, the developer of Aplidin and sponsor of the trial, announced its intent to submit a Marketing Authorization Application later this year to the European Medicines Agency.
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“Based on ADMYRE, the combination will be approved for heavily pretreated patients after treatment with conventional agents, such as proteasome inhibitors and immunomodulatory drugs,” said Dr Mateos. “It is early to recommend its use immediately, but subanalysis of ADMYRE will determine with more precision which patients might actually benefit from this combination.”
Dr Mateos said that the results of this trial are encouraging about the future of MM treatment.
“With many agents emerging for the treatment of patients with myeloma, I can envision promising new combinations around plitidepsin to enhance its activity and to contribute to prolonging the survival of myeloma patients,” she said.
- 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/2016/03/31/aplidin-shows-positive-results-in-pivotal-phase-iii-clinical-trial-for-multiple-myeloma/. Accessed May 12, 2016.
- National Cancer Institute. SEER Stat Fact Sheets: Myeloma. http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed May 12, 2016.