The most common all-grade non-hematologic AEs with and without elotuzumab, respectively, were fatigue (48% vs 40%), diarrhea (48% vs 37%), pyrexia (38% vs 28%), constipation (36% vs 28%), cough (33% vs 19%), and muscle spasms (30% vs 27%).
Infections of any grade were seen in 83% of patients in the elotuzumab arm compared with 75% with lenalidomide and dexamethasone alone. Once adjusting for treatment exposure, the rates were similar between the two arms. Infusion reactions, which were mostly grade 1/2, occurred in 10% of patients in the elotuzumab arm.
"Updated safety and tolerability data are consistent with previous findings, confirming that there is minimal incremental toxicity associated with the addition of elotuzumab to lenalidomide/dexamethasone," said Richardson.
A number of clinical trials continue to assess elotuzumab for patients with multiple myeloma. The ELOQUENT-1 trial is looking at elotuzumab in combination with lenalidomide and dexamethasone in newly diagnosed patients. Additionally, in the relapsed/refractory setting, elotuzumab is being assessed in combination with pomalidomide and dexamethasone and with the PD-1 inhibitor nivolumab.
"There's some very exciting trials going forward combining elotuzumab with other immuno-oncology agents, such as nivolumab, in the future," concluded Richardson.
Dimopoulos MA, Lonial S, White D, et al. Eloquent-2 Update: A Phase 3, Randomized, Open-Label Study of Elotuzumab in Combination with Lenalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma - 3-Year Safety and Efficacy Follow-up. Presented at: 57th American Society of Hematology Annual Meeting; Orlando, Florida; December 5-8, 2015. Abstract 28.
<<< View more from the 2015 ASH Annual Meeting