Empliciti Triple Combo Delays Disease Progression in Advanced Myeloma Patients, Phase 2 Trial Data Show
Adding Empliciti (elotuzumab) to a combination of Pomalyst (pomalidomide) and dexamethasone significantly delays disease worsening or death in myeloma patients who failed to respond to previous treatment, data from the Phase 2 ELOQUENT-3 trial show.
These results were recently shared at the 23rd European Hematology Association (EHA) Congress in Stockholm, in a presentation titled “Elotuzumab plus pomalidomide/dexamethasone (EPD) vs PD for treatment of relapsed/refractory multiple myeloma (RRMM): results from the Phase 2, randomized open-label ELOQUENT-3 study.”
The addition of Empliciti to Revlimid (lenalidomide) and dexamethasone showed promise in relapsed or refractory myeloma patients in a prior Phase 3 trial (NCT01239797). Patients lived longer without their disease progressing, and the treatment had an acceptable safety profile.
Pomalyst is an immunomodulatory agent similar to Revlimid, indicated to treat myeloma patients with disease progression despite at least two treatments, including Revlimid and a proteasome inhibitor — such as Velcade, Kyprolis or Ninlaro.
Because Pomalyst and Revlimid have a similar synergy with Empliciti, researchers now assessed if a combination of Emplicity, Pomalyst, and dexamethasone could be used in patients who had failed to respond to Revlimid.
The Phase 2 ELOQUENT-3 trial (NCT02654132) was designed to test for a first time if this triple combination was better at delaying disease progression or death in these advanced cancer patients, compared to Pomalyst and dexamethasone alone (control group). The study was conducted by Bristol-Myers Squibb, in collaboration with Celgene and AbbVie.
It recruited a total of 117 patients who had failed at least two prior lines of therapy, including Revlimid and a proteasome inhibitor.
Patients given the triple combination lived for a median of 10.3 months without their disease progressing, compared to 4.7 months in the control arm. This represented a 46 percent reduction in the risk or disease progression or death.
Overall response rate was also better in the triple combination — 53 versus 26 percent. This held true for very good partial responses or better, researchers said.
The rate of adverse effects was also lower in the Empliciti group, despite a longer exposure to the therapies — a median of nine cycles was given triple-combo patients and five given those in the control arm.
Fatalities were also higher in the control group (18 deaths) compared to the Emplicity group (13 deaths), and were mostly a consequence of disease progression.
Overall, the trial’s results support the addition of Empliciti to Pomalyst and dexamethasone for advanced myeloma patients who have failed to respond to prior treatment with Revlimid and a proteasome inhibitor, the researchers concluded.