The Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), has recommended that Empliciti (elotuzumab) in combination with Pomalyst (pomalidomide) and low-dose dexamethasone be approved to treat adults with relapsed or refractory multiple myeloma in Europe.
The therapy, collectively known as the EPd combo, is intended for patients who previously used at least two different therapies, including Revlimid (lenalidomide) and a proteasome inhibitor, and whose disease progressed while they were completing their last course of treatment.
“The positive opinion by the CHMP further validates the potential of this Empliciti-based combination to help patients with multiple myeloma who have relapsed or are refractory to prior therapies, a setting particularly in need of additional treatment options given the majority of patients with multiple myeloma will relapse,” Fouad Namouni, MD, head of Oncology Development, at Bristol-Myers Squibb, said in a press release.
Empliciti is an antibody therapy co-developed by Bristol-Myers Squibb and AbbVie that binds to a protein called SLAMF7. This protein is found on the surface of myeloma cells and anti-tumor natural killer (NK) cells.
The medication has two different effects: it stimulates the immune system to fight myeloma by activating NK cells through SLAMF7, and it tags cancer cells to be destroyed by NK cells by binding to them.
The U.S. Food and Drug Administration (FDA) approved the EPd combo to treat patients with advanced forms of multiple myeloma after at least two prior therapies, including Revlimid and a proteasome inhibitor, in November 2018.
A type II variation refers to any major change in a drug’s marketing authorization that may have a strong impact on the product’s quality, safety or efficacy, but does not include alterations of its active ingredient, dosage, or mode of administration.
The EMA application was based on findings from the global, open-label, and randomized ELOQUENT-3 Phase 2 trial (NCT02654132). The study assessed the effects of adding Empliciti to standard treatment with Pomalyst and low-dose dexamethasone (Pd combo) in 117 patients with relapsed or refractory multiple myeloma whose disease worsened despite treatment with at least two prior therapies.
Study participants were randomly assigned to either the EPd combo or the standard Pd combo in treatment cycles of 28 days, until disease progression or unacceptable toxicity.
Its primary goal was an increase in the number of patients responding to treatment, and findings showed the EPd combination doubled the response rate compared to Pd: 53% versus 26%.
Triple combination therapy also lowered patients’ risk of death by 46%, and increased the amount of time patients lived without their disease progressing.
About a third (34%) of the patients on the EPd combo showed no signs of disease worsening after 18 months of treatment, compared to 11% of those given the Pd combo.
Safety assessments indicated the frequency and severity of adverse events were similar in both treatment groups and consistent with findings from previous studies. The most common serious side effects reported during the trial included infections, neutropenia (low white blood cell counts), anemia, thrombocytopenia (low platelet counts), and low blood sugar.
The European Commission is now reviewing CHMP’s recommendation and will decide if the triple combination therapy will also be approved for use in the EU.