The addition of the investigative agent Aplidin® (plitidepsin) to dexamethasone appears to significantly reduce the risk of cancer progression or death compared to dexamethasone alone among patients with multiple myeloma that has progressed following prior therapies.
Multiple myeloma is a type of blood cancer that affects certain immune cells called plasma cells. Healthy plasma cells produce proteins called antibodies that are an important part of the immune system’s defense for fighting bacteria and viruses.
Cancerous plasma cells tend to replicate at a fast pace, crowding out other healthy immune cells, as well as producing malfunctioning antibodies. These antibodies tend to cause damage to the kidneys, in addition to reducing the immune system’s ability to efficiently fight infection.
Researchers continue to evaluate novel treatment options for multiple myeloma, particularly among patients whose disease has progressed or returned despite prior therapies (referred to as recurrent or refractory disease). Novel therapeutic agents that do not tend to create the severity of side effects associated with chemotherapy continue to be developed for the treatment of various types of cancers, including multiple myeloma. Studies are ongoing to explore optimal combinations and sequences of regimens containing these novel compounds.
Plitidepsin, originally derived from the marine animal ascidian Aplidium albicans, is the first agent in a class that targets a protein referred to as eEF1A2. This particular protein enhances a cancer cell’s ability to replicate and spread. By specifically targeting eEF1A2, plitidepsin reduces the effects of eEF1A2 and therefore, decreases cancer growth caused by the protein.
The recent clinical trial evaluating plitidepsin in multiple myeloma was an international phase III clinical trial referred to as ADMYRE. This trial included 255 patients in 82 medical centers across 19 countries. Patients had multiple myeloma that had progressed or returned following at least 3, but less than 6, prior therapies.
Patients in this trial were divided into two groups: one group was treated with plitidepsin plus dexamethasone, and a second group was treated with dexamethasone only (a standard treatment approach for multiple myeloma). Results from the two groups were directly compared.
- Overall, patients who were treated with the combination of plitidepsin and dexamethasone experienced a 35% reduction in the risk of cancer progression or death, compared to those who were treated with dexamethasone only.
These results demonstrate a significant improvement with the addition of plitidepsin to dexamethasone among patients with relapsed or refractory multiple myeloma. More detailed data and results of this trial will be submitted for presentation at an upcoming medical conference.
Reference: PharmaMar. Press release March 31, 2016. Aplidin® shows positive results in pivotal Phase III clinical trial for multiple myeloma. Available at: https://www.pharmamar.com/2016/03/31/aplidin-shows-positive-results-in-pivotal-phase-iii-clinical-trial-for-multiple-myeloma/. Accessed April 14, 2016.
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