On June 17th, BMS announced at the EHA 2018 annual meeting that phase II ELOQUENT-3 study reached the primary endpoint, Empititi (elotuzumab) combined with poloximatil and low-dose dexamethasone (EPd regimen) compared to using pomametide alone And dexamethasone (Pd regimen) can significantly improve progression-free survival in patients with relapsed or refractory multiple myeloma.
The ELOQUENT-3 study is currently the only randomized, positive controlled study evaluating the use of pomametide for relapsed and refractory MM patients who have previously received at least two treatments including lenalidomide plus a proteasome inhibitor. The data showed that the risk of disease progression in the EPd-treated group (n=60) was 46% lower than in the Pd-treated group (n=57), and the PFS was 10.3 and 4.7 months, respectively.
ORR in the EPd-treated group was twice that of the Pd-treated group (53% vs 26%). The time to first respond to the EPd group was comparable (1.95 vs 1.91 months), median response duration, and median survival data. Not yet mature.
In terms of safety, the ELOQUENT-3 study was consistent with the previous findings of Empliciti. The incidence of grade 3–4 adverse events was similar between the two groups, and the incidence of infection at any level was 65%. In the most common grade 3 to 4 hematologic adverse events (neutropenia and anemia), The EPd treatment group was lower than the Pd treatment group (13%, 10% vs. 27%, 20%). The proportion of patients who discontinued treatment in the EPd group was 18%, compared with 24% in the Pd group.
Empliciti is the only monoclonal antibody targeting SLAMF7 (a member of the signal transduction lymphocyte activation molecule family 7) that was launched in the world. It was first approved by the FDA on 2015/11/30 for second-line or third-line treatment with lenalidomide and dexamethasone. Relapsed or refractory MM, jointly developed by BMS and AbbVie, BMS alone responsible for commercial promotion and sales, global sales in 2017 was 231 million US dollars.