OncLive Shares Updated Data for Newly-Approved Myeloma Drugs Daratumumab and Elotuzumab
The CD38 monoclonal antibody daratumumab (Darzalex) demonstrated a 31% overall response rate (ORR) as monotherapy for patients with heavily pretreated multiple myeloma, according to a combined analysis of two pivotal studies presented at the 2015 ASH Annual Meeting. In combined data from the GEN501 and SIRIUS studies, the rate of complete response plus very good partial response was 13% for patients treated with daratumumab at 16 mg/kg. The 12-month progression-free survival (PFS) rate was 50% and median overall survival (OS) was 19.9 months. “As a single agent, daratumumab induced rapid, deep, and durable responses in a heavily pretreated/highly refractory population,” said lead investigator Saad Z. Usmani, MD, Levine Cancer Institute/Carolinas Healthcare System. “Remarkable depth of response was observed in patients refractory to newer agents, including pomalidomide and carfilzomib.” In addition to single-agent activity, daratumumab is also being explored in a number of combination studies. At this time, several phase III clinical trials are looking at the antibody in various treatment settings. To read the entire article in OncLive, click here. To find clinical trials using daratumumab, visit Spark Cures by clicking here. Benefits of Elotuzumab Sustained in 3-Year Myeloma Data The combination of elotuzumab (Empliciti), lenalidomide (Revlimid), and dexamethasone showed sustained improvements in progression-free survival (PFS) and overall survival (OS) for patients with relapsed/refractory multiple myeloma, according to a 3-year analysis of the ELOQUENT-2 trial. In updated data from the phase III study, the addition of the SLAMF7 antibody reduced the risk of progression or death by 27% and overall survival (OS) was improved by 4.1 months versus lenalidomide and dexamethasone alone. Additionally, the minimal incremental toxicity observed with elotuzumab remained consistent. “Elotuzumab, a novel first-in-class immunostimulatory monoclonal antibody, in combination with lenalidomide and dexamethasone demonstrated a durable and clinically relevant improvement in both progression-free survival and overall response rate,” senior investigator Paul G. Richardson, MD, from the Dana-Farber Cancer Institute, said during a presentation of the data. “I'm very please to see that this benefit was sustained. Very importantly, we see a delay in next therapy, which is very relevant.” On November 30, 2015, the FDA approved elotuzumab in combination with lenalidomide (Revlimid) and dexamethasone for patients with multiple myeloma following progression on 1 to 3 prior therapies. This decision was based on a 2-year analysis of the ELOQUENT-2 trial, which showed a 30% improvement in PFS with the addition of elotuzumab compared with lenalidomide/dexamethasone alone. In the 2-year data that were the basis for the FDA approval, the ORR was 79% with elotuzumab versus 66% with lenalidomide/dexamethasone alone. Median PFS with elotuzumab was 19.4 versus 14.9 months with lenalidomide and dexamethasone alone. At this point, OS data were not yet mature. "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. To read the article in its entirely from OncLive, click here. To find clinical trials using elotuzumab, visit Spark Cures here.