During the European Hematology Association’s 23rd Congress, held from June 14 to 17 in Stockholm, Sweden, researchers announced that the ELOQUENT-3 phase 2 study, evaluating elotuzumab with pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, met its primary endpoint in showing a statistically significant, clinically meaningful improvement in progression-free survival.
During the European Hematology Association’s 23rd Congress, held from June 14 to 17 in Stockholm, Sweden, researchers announced that the ELOQUENT-3 phase 2 study, evaluating elotuzumab with pomalidomide and low-dose dexamethasone (EPD) in patients with RRMM, met its primary endpoint in showing a statistically significant, clinically meaningful improvement in progression-free survival (PFS) in patients treated with EPD versus PD alone.
Elotuzumab, an immunestimulatory antibody, targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), which is expressed on myeloma cells as well as Natural Killer cells and plasma cells. The drug has a dual method of action: it activates the immune system through Natural Killer cells via the SLAMF7 pathway, and also targets SLAMF7 on myeloma cells.
The ELOQUENT-3 study compared the efficacy and safety EPD versus PD alone in 177 patients with RRMM who had received 2 or more previous lines of therapy. Sixty patients were randomized to receive EPD and 57 were randomized to receive PD. The median number of lines of therapy received was 3 (range, 2-8).
Patients in the EPD group showed a 46% reduction in risk of progression or death versus those in the PD group (hazard ratio, 0.54; 95% CI, 0.34-0.86; P =.0078). Median PFS in the EPD group was 10.3 months (range, 5.6 to a non-estimable upper limit) versus 4.7 months (range, 2.8-7.2) with PD.
Overall response rate was 53% with EPD versus 26% with PD, and a very good partial response or better was observed in 20% of the EPD group versus 9% of the PD group.
“These data support the hypothesis that the addition of elotuzumab to pomalidomide and dexamethasone elicits a synergistic effect and prolongs, significantly, the progression-free survival of heavily pretreated patients with myeloma, regardless of the number of prior therapies,” Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine, and lead author of the study, said in a statement.
Infections of any grade occurred in 65% of patients in both arms. Adverse events (AEs) of grade 3 to grade 4 neutropenia and anemia were lower with EPD (13% and 10%, respectively) than with PD (27% and 20%, respectively). AEs led to discontinuation 18% of the EPD group and 24% of the PD group.
“We believe that EPD, if approved by regulatory authorities, could become an important potential treatment option for patients with [RRMM] whose disease has progressed after treatment with lenalidomide and a proteasome inhibitor,” he added.
Dimopoulos MA, Dytfelt D, Grosicki S, et al. Elotuzumab plus pomalidomide/dexamethasone (EPD) vs PD for treatment of relapsed/refractory multiple myeloma (RRMM): results from the phase 3, randomized open-label ELOQUENT-3 study. TK. Abstract LB2606. https://learningcenter.ehaweb.org/eha/2018/stockholm/218888/meletios.a.dimopoulos.elotuzumab.plus.pomalidomide.dexamethasone.28epd29.vs.pd.html?f=topic=1574*media=3.