Empliciti Combo Fails to Stem Progression of Newly Diagnosed Multiple Myeloma

Empliciti (elotuzumab), in combination with Revlimid (lenalidomide) and dexamethasone, did not significantly extend the time people with multiple myeloma lived without disease progression, compared with Revlimid and dexamethasone alone, topline data from a Phase 3 clinical trial showed.

While the ELOQUENT-1 trial (NCT01335399), which included newly diagnosed myeloma patients who were not eligible for stem cell transplants, failed to achieve its main goal of progression-free survival, safety was consistent with the known profile of the combination.

Bristol Myers Squibb and AbbVie, which are co-developing Empliciti, plan to complete evaluating ELOQUENT-1’s data and present the findings at a future medical meeting.

“While we are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant-ineligible patients, the Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options,” Noah Berkowitz, MD, PhD, senior vice president for global clinical development, hematology, at Bristol Myers Squibb, said in a press release.

Empliciti is an antibody that binds the SLAM7 molecule, found at the surface of myeloma cells and of some immune cells called natural killer (NK) cells. The therapy has a dual mechanism of action, activating direct and immune-mediated cell death mechanisms.

Empliciti is used in combination with Revlimid and dexamethasone for the treatment of multiple myeloma patients who failed prior therapies. But studies suggested that people receiving this combination in earlier lines of therapy would draw the highest benefits.

This led researchers to design a Phase 3 trial assessing if a combination of Empliciti, Revlimid and low-dose dexamethasone would also improve the outcomes of people who had never received treatment for their myeloma and were not suitable for stem cell transplant due to their age (65 or older) or to pre-existing conditions.

ELOQUENT-1 enrolled about 750 people who received the triple combo, or Revlimid and low-dose dexamethasone only, continuously until their disease progressed. The primary goal was to determine if Empliciti extended the time patients live without disease progression, and secondary endpoints included the proportion of patients responding to treatment and overall survival.

A final analysis showed that the trial failed to meet its primary goal, though the companies have not yet disclosed the data leading to the announcement. That data, along with findings from the trial’s secondary goals, will be presented soon at a scientific conference.

“Multiple myeloma is an aggressive disease characterized by relapse and the likelihood to be refractory to several therapies,” said Meletios A. Dimopoulos, MD, chairman of the department of clinical therapeutics at Kapodistrian University of Athens School of Medicine.

“While the elotuzumab, lenalidomide and dexamethasone combination was unable to show a benefit in patients with newly diagnosed multiple myeloma at this time, it remains an important treatment option in the relapsed/refractory setting,” Dimopoulos said.